Gelman Sciences, Inc.
Mchenry, IL, US
Gelman Sciences, Inc. appears in FDA device records in Mchenry, IL. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Gelman Sciences, Inc. between 1979 and 1995. The busiest year on record is 1981, with 7. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 7 |
| 1982 | 3 |
| 1983 | 1 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 1 |
| 1989 | 4 |
| 1991 | 1 |
| 1994 | 5 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K946190 | DRUG DISPENSING SPIKE | FMF | Substantially Equivalent | |
| K943127 | PHARMASSURE LARGE VOLUME TRANSFER FILTERS | FPB | Substantially Equivalent | |
| K941589 | SYRINGE FILTER DEVICES | FMF | Substantially Equivalent | |
| K941020 | DRUG RECONSTITUTION FILTER DEVICE | FMF | Substantially Equivalent | |
| K942275 | VIAL VENT FILTER | FPB | Substantially Equivalent | |
| K941032 | UNKNOWN | FMF | Substantially Equivalent | |
| K910821 | TRANSDUCER PROTECTOR | FIB | Substantially Equivalent | |
| K892387 | MODIFIED GELMAN ARTERIAL FILTER | DTM | Substantially Equivalent | |
| K884176 | CHROMATOGRAPHY KIT | DPA | Substantially Equivalent | |
| K884178 | DRUG CONTROL SET | DIF | Substantially Equivalent | |
| K884177 | DRUG STANDARD SET | DKB | Substantially Equivalent | |
| K862068 | GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) | DTM | Substantially Equivalent | |
| K850260 | GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER | JQT | Substantially Equivalent | |
| K850202 | GELMAN TRIPHOR CONTROL | JJY | Substantially Equivalent | |
| K842052 | GIARDIA GUARD | LIB | Substantially Equivalent | |
| K842560 | OPTIPHOR-10 | JJN | Substantially Equivalent | |
| K842485 | OPTICLEAR | JJN | Substantially Equivalent | |
| K823550 | CK-ISOZYME U.V. REAGENT SET | JHT | Substantially Equivalent | |
| K822121 | ACRO PACK | JRL | Substantially Equivalent | |
| K821303 | HI-PHORE HIGH RESOLUTION ELECTROPHORES | JJN | Substantially Equivalent | |
| K820518 | GELMAN GLYCO-PHORE BUFFER | JBD | Substantially Equivalent | |
| K813159 | VACUSHIELD TM | JRL | Substantially Equivalent | |
| K812539 | PRE-BYPASS FILTER | KRJ | Substantially Equivalent | |
| K812253 | GELMAN IG-FIX KIT | CZP | Substantially Equivalent | |
| K811100 | GELMAN ELECTROPHORESIS CONTROL | JJY | Substantially Equivalent | |
| K810829 | ACRODISC | JRL | Substantially Equivalent | |
| K810047 | AUTOPHOR 128 | JBD | Substantially Equivalent | |
| K802765 | ACRODISC FILTER ASSEMBLY | FPB | Substantially Equivalent | |
| K801378 | HIPP BUFFER(NON-BARBITAL), P/N | JJN | Substantially Equivalent | |
| K791606 | GELMAN LIPOPROTEIN FRS SET. P/N 51213 | JHO | Substantially Equivalent | |
| K791111 | AUTOMATED ELECTROPHORESES MACHINE | JJN | Substantially Equivalent | |
| K790791 | ELECTROPHORESIS REAGENT SET, HDL | LBT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJNApparatus, Electrophoresis, For Clinical Use
- DPAApparatus, General Use, Thin Layer Chromatography
- DKBCalibrators, Drug Mixture
- JHTChromatographic Separation, Cpk Isoenzymes
- JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- LIBDevice, General Purpose, Microbiology, Diagnostic
- DIFDrug Mixture Control Materials
- LBTElectrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
- JHOElectrophoretic Separation, Lipoproteins
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- FPBFilter, Infusion Line
- KRJFilter, Prebypass, Cardiopulmonary Bypass
- CZPIga, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- FIBProtector, Transducer, Dialysis
- FMFSyringe, Piston
- JBDSystem, Analysis, Electrophoretic Hemoglobin
- JRLUnit, Filter, Membrane
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain