Dade Intl., Inc.
Deerfield, IL, US
Dade Intl., Inc. appears in FDA device records in Deerfield, IL. FDA records list 30 510(k) clearances between and , 28 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
- 30
- PMA records
- 28
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 30 510(k) clearances for Dade Intl., Inc. between 1995 and 1998. The busiest year on record is 1997, with 14. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 4 |
| 1996 | 11 |
| 1997 | 14 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K974343 | DADE INNOVIN | GJS | Substantially Equivalent | |
| K970505 | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ | JOZ | Substantially Equivalent | |
| K973974 | DADE TRU-LIQUID CARDIAC CONTROL | JJT | Substantially Equivalent | |
| K973668 | CARDIAC TROPONIN-I (TROP) CALIBRATOR | JIT | Substantially Equivalent | |
| K972524 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K972782 | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | JHX | Substantially Equivalent | |
| K972287 | DADE TRU-LIQUID BILIRUBIN CONTROL | JJX | Substantially Equivalent | |
| K964660 | PARAMAX CHOLESTEROL REAGENT | CHH | Substantially Equivalent | |
| K970676 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K964715 | PARAMAX SALICYLATE REAGENT | DKJ | Substantially Equivalent | |
| K970330 | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE | CEM | Substantially Equivalent | |
| K964346 | PARAMAX TRIGLYCERID REAGENT | CDT | Substantially Equivalent | |
| K965213 | STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY | DDR | Substantially Equivalent | |
| K964862 | TROPONIN-I TEST SYSTEM | MMI | Substantially Equivalent | |
| K964139 | SYSMEX CA-6000 | GKP | Substantially Equivalent | |
| K964565 | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT | JIF | Substantially Equivalent | |
| K963244 | ACETAMINOPHEN FLEX REAGENT CARTRIDGE | LDP | Substantially Equivalent | |
| K962817 | DRUG CALIBRATOR II | DKB | Substantially Equivalent | |
| K963267 | VANCOMYCIN FLEX REAGENT CARTRIDGE | LEH | Substantially Equivalent | |
| K962820 | CARBAMAZEPINE FLEX REAGENT CARTRIDGE | KLT | Substantially Equivalent | |
| K962819 | GENTAMICIN FLEX REAGENT CARTRIDGE | LCD | Substantially Equivalent | |
| K962818 | TOBRAMYCIN FLEX REAGENT CARTRIDGE | LCR | Substantially Equivalent | |
| K962150 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | |
| K962602 | ACA PLUS FREE THYROXINE(FT4) METHOD | CEC | Substantially Equivalent | |
| K962594 | ACA PLUS FT4 CALIBRATOR | JIT | Substantially Equivalent | |
| K960103 | DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS | JIX | Substantially Equivalent | |
| K952250 | STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT | JHS | Substantially Equivalent | |
| K951890 | STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS | MMI | Substantially Equivalent | |
| K951888 | DADE STRATUS TROPONIN-I CONTROL | JJX | Substantially Equivalent | |
| K951332 | PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT | CKA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- DKBCalibrators, Drug Mixture
- LDPColorimetry, Acetaminophen
- DKJColorimetry, Salicylate
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- CEMElectrode, Ion Specific, Potassium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JIFEnzymatic Method, Ammonia
- JJTEnzyme Controls (Assayed And Unassayed)
- KLTEnzyme Immunoassay, Carbamazepine
- LCDEnzyme Immunoassay, Gentamicin
- LCRFluorescent Immunoassay, Tobramycin
- JHXFluorometric Method, Cpk Or Isoenzymes
- MMIImmunoassay Method, Troponin Subunit
- GKPInstrument, Coagulation, Automated
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- JWYManual Antimicrobial Susceptibility Test Systems
- DDRMyoglobin, Antigen, Antiserum, Control
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- LTTPanels, Test, Susceptibility, Antimicrobial
- CECRadioimmunoassay, Free Thyroxine
- LEHRadioimmunoassay, Vancomycin
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JOZSystem, Automated Platelet Aggregation
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- GJSTest, Time, Prothrombin
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