Fisher Scientific Company L.L.C.
Pittsburgh, PA, US
FISHER SCIENTIFIC COMPANY L.L.C. appears in FDA device records in Pittsburgh, PA. FDA records list 89 510(k) clearances between and , one PMA record and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 89FDA records hold 89 510(k) clearances for Fisher Scientific Company L.L.C. between 1976 and 1993. The busiest year on record is 1983, with 20. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1978 | 8 |
| 1979 | 17 |
| 1980 | 8 |
| 1981 | 6 |
| 1982 | 6 |
| 1983 | 20 |
| 1984 | 6 |
| 1985 | 4 |
| 1986 | 4 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 1 |
| 1992 | 2 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K930415 | MICROHEMATOCRIT ROTOR | GKG | Substantially Equivalent | |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | GKF | Substantially Equivalent | |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | GKF | Substantially Equivalent | |
| K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 | JJW | Substantially Equivalent | |
| K881275 | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II | JJY | Substantially Equivalent | |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | GGK | Substantially Equivalent | |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | KPA | Substantially Equivalent | |
| K871058 | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) | JJY | Substantially Equivalent | |
| K863224 | HEMATALL-C PLUS HEMATOLOGY CONTROLS | JPK | Substantially Equivalent | |
| K862318 | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR | JPK | Substantially Equivalent | |
| K861185 | THERACHEM-PLUS, TRI-LEVEL TDC (TM) | JJY | Substantially Equivalent | |
| K860919 | THERACHEM, TDC THERAPEUTIC DRUG CONTROLS | DIF | Substantially Equivalent | |
| K853241 | HEMATOLOGY STAIN PACK | IAF | Substantially Equivalent | |
| K851151 | FISHER DIAGNOSTICS KDA CALIBRATOR II | JIX | Substantially Equivalent | |
| K851150 | FISHER DIAGNOSTICS KDA CALIBRATOR I | JIX | Substantially Equivalent | |
| K850636 | SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E | KDX | Substantially Equivalent | |
| K844168 | AMYLASE REAGENT CS-726 | CJA | Substantially Equivalent | |
| K843452 | STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ | JGS | Substantially Equivalent | |
| K840111 | TOTAL BILIRUBIN | CIG | Substantially Equivalent | |
| K833950 | TOTAL PROTEIN REAGENT CS-724 | CEK | Substantially Equivalent | |
| K833712 | NA/K FLUIDA PACK FOR NOVA 1 ANALYZER | JGS | Substantially Equivalent | |
| K833699 | ALBUMIN REAGENT CS-716 | CIX | Substantially Equivalent | |
| K833035 | CALCIUM DYE REAGENT-CS-718-A/BUFFER | CIC | Substantially Equivalent | |
| K832879 | B-SLIDE PREGNATE PREGNANCY TEST KIT | JHJ | Substantially Equivalent | |
| K831025 | ELECTROLYLE CARBON DIOXIDE ELECTRODES | CHL | Substantially Equivalent | |
| K831024 | ELECTROLYTE PO2 FOR OXYGEN ELECTRODES | CHL | Substantially Equivalent | |
| K831021 | CALIBRATING SOLUTION FOR ABL-1 & 2 | CHL | Substantially Equivalent | |
| K831019 | PH 6.838 REF. BUFFER | CHL | Substantially Equivalent | |
| K831018 | CALIBRATING SOLUTION FOR ABL-1 & 2 | CHL | Substantially Equivalent | |
| K831023 | REFERENCE BUFFER PH 7.382 | CHL | Substantially Equivalent | |
| K831013 | DIAGNOSTICS PO 2 ELECTROLYTE | CHL | Substantially Equivalent | |
| K831012 | DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON | CHL | Substantially Equivalent | |
| K831015 | DIAGNOSTICS PH ELECTRODE CLEANING SOLUT | CHL | Substantially Equivalent | |
| K831020 | FLUSH SOLUTION CONCENTRATE | CHL | Substantially Equivalent | |
| K831017 | BUFFER PACK FOR ABL-1 & ABL-2 | CHL | Substantially Equivalent | |
| K831016 | BATH CLEAR | CHL | Substantially Equivalent | |
| K831010 | DIAGNOSTICS PO2 ELECTRODE CLEANER | CHL | Substantially Equivalent | |
| K830578 | MICROHEMATOCRIT READER | JPI | Substantially Equivalent | |
| K830217 | REAGENTS CORNING CHLORIDE METER FOR | JFS | Substantially Equivalent | |
| K823930 | HEMATOLOGY QUALITY CONTROL MIXTURE | GJP | Substantially Equivalent | |
| K823929 | MULTIANALYTE CONTROLS-ALL KINDS | JJY | Substantially Equivalent | |
| K823558 | MICRO-HEMATOCRIT CENTRIFUGE 335/336 | JPI | Substantially Equivalent | |
| K822905 | LATEST RF KIT FOR RHEUMATOID FACTOR | DHR | Substantially Equivalent | |
| K822496 | SERA CHEM SMAC CALIBRATORS | JIT | Substantially Equivalent | |
| K822352 | HEMATOXYLIN STAIN SOLUTION | HYJ | Substantially Equivalent | |
| K821683 | REAGENT FOR COULTER COUNTER MODEL 5+11 | GIF | Substantially Equivalent | |
| K820731 | HEMATALL-C PLUS HEMATOLOGY CONTROLS | JPK | Substantially Equivalent | |
| K820996 | SALMONELLA & SHIGELLA GROUPING SERA | GRL | Substantially Equivalent | |
| K813505 | FLAME PHOTOMETER CALIBRATION STANDARDS | JIS | Substantially Equivalent | |
| K812623 | CLEANING SOLUTION FOR RADIOMETER OSM2 | CHL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2517925 | 2517925 | FISHER SCIENTIFIC COMPANY L.L.C. | 300 Industry Dr, PITTSBURGH, PA 15275 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CDHAcid, Uric, Phosphotungstate Reduction
- JHJAgglutination Method, Human Chorionic Gonadotropin
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CJAAmyloclastic, Amylase
- GRLAntigens, All Groups, Salmonella Spp.
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- GKGCentrifuge, Hematocrit
- GJPControl, Platelet
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- JFSCoulometric, Chloride
- CICCresolphthalein Complexone, Calcium
- JSCCulture Media, General Nutrient Broth
- JPIDevice, Hematocrit Measuring
- CDWDiacetyl-Monoxime, Urea Nitrogen
- CIGDiazo Colorimetry, Bilirubin
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- GIFDiluent, Blood Cell
- DIFDrug Mixture Control Materials
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CDSElectrode, Ion Specific, Urea Nitrogen
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CGAGlucose Oxidase, Glucose
- LGBGonococcal Antibody Tests
- HYJHematoxylin
- CFRHexokinase, Glucose
- GKFInstrument, Hematocrit, Automated
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- KSGMedia, Potentiating For In Vitro Diagnostic Use
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CGEOrthotoluidine, Glucose
- JFLPh Rate Measurement, Carbon-Dioxide
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- GGKProducts, Red-Cell Lysing Products
- KPASlide Stainer, Automated
- KDXSolution, Decalcifier, Acid Containing
- DHRSystem, Test, Rheumatoid Factor
- JJWUrinalysis Controls (Assayed And Unassayed)
- LYZVinyl Patient Examination Glove
- IAFWright'S Stain
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1521-2014 | Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack culture collection and industrial surfaces | A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab. | Class II | Terminated | |
| Z-1955-2013 | Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient. | The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain