Clinical Chemistry
13,051 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| SERACON-HDL (K782171) | Bhp Diagnostix, Inc. | 1979-02-08 |
| CONTROL STRIP FOR VISUAL URINALYSIS (K781961) | Miles Laboratories, Inc. | 1979-02-08 |
| SERACON-A (K782037) | Bhp Diagnostix, Inc. | 1979-02-08 |
| SERUM, LACTIC DEHYDROGENASE (K790020) | Fisher Scientific Co., LLC | 1979-02-08 |
| SERACON-C (K782038) | Bhp Diagnostix, Inc. | 1979-02-08 |
| SHAKER, MODEL SH-510 (K790027) | Sysmex Corp. | 1979-02-08 |
| SERUM, POTASSIUM DETERMINATION OF (K790018) | Fisher Scientific Co., LLC | 1979-02-01 |
| RIA KIT, IMMO PHASE (K781953) | Corning Medical & Scientific | 1979-02-01 |
| DIAGNOSTIC KIT, FERRITAB-FE-59 (K782159) | Leeco Diagnostics, Inc. | 1979-02-01 |
| A-GENT CK-MB (K782015) | Abbott Laboratories | 1979-02-01 |
| EMIT THYROXINE ASSAY (K782085) | Syva Co. | 1979-02-01 |
| PREGNANCY TEST KIT, DAISY 2 IN HOME (K790002) | Boehringer Mannheim Corp. | 1979-02-01 |
| RIA KIT, RIANEN CORTISOL (K782110) | New England Nuclear | 1979-01-26 |
| TOTAL IRON IN SERUM (K782160) | Fisher Scientific Co., LLC | 1979-01-26 |
| GLUCOSE REAGENT SYSTEM (K782136) | American Monitor Corp. | 1979-01-26 |
| RIA KIT, GAMMACOAT (K782109) | Clinical Assays, Inc. | 1979-01-26 |
| RIA KIT, QUANTITOPE CORTISOL (K781903) | Kallestad Laboratories, Inc. | 1979-01-26 |
| KETOSTEROID TEST, HYCEL-17 (K782116) | Hycel, Inc. | 1979-01-26 |
| HYCEL LDH-INT TEST (K782176) | Hycel, Inc. | 1979-01-26 |
| RIA KIT, NEONATAL T4 (K782103) | Serono Laboratories, Inc. | 1979-01-17 |
| HEMESPEC (K782035) | Helena Laboratories | 1979-01-17 |
| PROCESSOR, K750 COMPUTER/DATA (K782052) | Kallestad Laboratories, Inc. | 1979-01-17 |
| GLUCOSE OXIDASE REAGENT (K781945) | Fermco Biochemics, Inc. | 1979-01-17 |
| REAGENT SYSTEM, INORGANIC PHOSPHORUS (K781806) | Sigma Chemical Co. | 1979-01-17 |
| HILAR (K782094) | Hi Chem, Inc. | 1979-01-17 |
| CALCITONIN 125 (K781909) | Cambridge Nuclear Radiopharmaceutical | 1979-01-10 |
| BUN (K781782) | Gilford Diagnostics | 1979-01-10 |
| REAGENT KIT, TRIGLYCERIDES (K781939) | Beckman Instruments, Inc. | 1979-01-10 |
| HORMONE KIT, PARATHYROID (K782010) | Nichols Institute Diagnostics | 1979-01-10 |
| DATA MODULE (K781915) | Waters Assoc., Inc. | 1979-01-10 |
| RIA KIT, GAMMADAB ESTRIOL (K781938) | Clinical Assays, Inc. | 1979-01-10 |
| RIA TEST, NORDICALB HPL (K782099) | Nordiclab Intl. | 1979-01-10 |
| ANALYZER ABA-200 (K782014) | Abbott Laboratories | 1979-01-10 |
| STAT KIT, MICROPROTEIN (K781897) | Pierce Chemical Co. | 1979-01-10 |
| EXETRELUT (K782066) | Mcb Manufacturing Chemists, Inc. | 1979-01-03 |
| CHOLESTEROL REAGENT SUBSTRATE SET (K781970) | Corning Medical & Scientific | 1979-01-03 |
| AST (K781784) | Gilford Diagnostics | 1979-01-03 |
| BILIRUBIN, DINGLE VALVE DPD (K781921) | Boehringer Mannheim Corp. | 1979-01-03 |
| BLOOD GAS SYSTEM MODEL 168 (K781968) | Corning Medical & Scientific | 1979-01-03 |
| RIA KIT, QUANTITOPE T3 UPTAKE (K781905) | Kallestad Laboratories, Inc. | 1979-01-03 |
| RIA, QUANTIMUNE E3 (K781850) | Bio-Rad | 1979-01-03 |
| ACID REAGENT, URIC SINGLE VIAL (K781996) | Calbiochem-Behring Corp. | 1979-01-03 |
| BETA-TEC (K781794) | Wampole Laboratories | 1978-12-29 |
| ANALYZER, AUTOMED CENTRIFUGAL (K781900) | Autogenic Systems | 1978-12-20 |
| CONTROL, PROTEIN ELECTROPHORESIS (K781893) | Sigma Chemical Co. | 1978-12-20 |
| EXTUBE (K781728) | Analytichem International, Inc. | 1978-12-20 |
| CLEARING SOLUTION #ECA01976 (K781898) | Electrophoresis Corp. of America | 1978-12-20 |
| DETECTOR, MODEL 79875A, VARIABLE (K781771) | Hewlett-Packard Co. | 1978-12-20 |
| UROTRON (K781632) | Boehringer Mannheim Corp. | 1978-12-20 |
| SERUM, CREATININE DETERMINATIONS (K781884) | Fisher Scientific Co., LLC | 1978-12-20 |
| SERUM, BLOOD UREA NITIOGEN (K781885) | Fisher Scientific Co., LLC | 1978-12-20 |
| RIA KIT, PREG-STAT (K781733) | Serono Laboratories, Inc. | 1978-12-20 |
| UREA NITROGEN TEST (K781899) | Wako Intl., Inc. | 1978-12-20 |
| CHEMSTRIP CONTROL (K781691) | Boehringer Mannheim Corp. | 1978-12-20 |
| REAGENT SYSTEM, NO 46-OV FOR CPK (K781859) | Sigma Chemical Co. | 1978-12-04 |
| SERACON-SRII (K781758) | Bhp Diagnostix, Inc. | 1978-12-04 |
| BLOOD SUGAR (K781783) | Gilford Diagnostics | 1978-12-04 |
| COMPUTER, 3500, GILFORD SYSTEM (K781828) | Syva Co. | 1978-12-04 |
| PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS (K781000) | Abbott Laboratories | 1978-12-04 |
| SERACON-SRI (K781757) | Bhp Diagnostix, Inc. | 1978-12-04 |
| CHOLESTEROL STANDARDS (K781853) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-12-04 |
| ELISA SYSTME (K781269) | Gilford Instrument Laboratories, Inc. | 1978-12-04 |
| IRON BINDING CAPICITY MODEL 0370 (K781865) | Stanbio Laboratory | 1978-12-04 |
| DIRECT ESTRIOL RIA KIT (K781546) | Immunalysis Corporation | 1978-12-04 |
| DILUTER, LSA 290 PIPETTER (K781883) | Kallestad Laboratories, Inc. | 1978-12-04 |
| IRON 59 KIT (K781769) | Ria Products, Inc. | 1978-12-04 |
| REAGENT, HDL (K781740) | Fisher Scientific Co., LLC | 1978-11-22 |
| LDH REAGENT SYSTEM (K781765) | American Monitor Corp. | 1978-11-22 |
| TOTAL PROTEIN (K781774) | Gilford Diagnostics | 1978-11-22 |
| ALBUMIN REAGENT (K781773) | Gilford Diagnostics | 1978-11-22 |
| RIA, CORTISOL KIT (K781730) | Radioassay Systems Laboratories, Inc. | 1978-11-22 |
| LDH (K781775) | Gilford Diagnostics | 1978-11-22 |
| 125I-ALDOSTERONE RIA DIAG. KIT (K781504) | Abbott Laboratories | 1978-11-22 |
| CALIBRATOR, BOVINE SERUM (K781702) | Bio-Reagents & Diagnostics, Inc. | 1978-11-15 |
| ACCUSCREEN T4 (K781222) | Neometrics, Inc. | 1978-11-08 |
| RIA, T3 UPTAKE SOLID PHASE (K781662) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-11-08 |
| HBDH ENZYME KINETIC REAGENT SET (K781720) | Medical Analysis Systems, Inc. | 1978-11-03 |
| REAGENT SET, TOTAL PROTEIN (K781722) | Medical Analysis Systems, Inc. | 1978-11-03 |
| GLUCOSE HEXOKINASE, AUTO K (K781723) | Medical Analysis Systems, Inc. | 1978-11-03 |
| REAGENT SET, SGPT SERUM GLUTAMIC (K781726) | Medical Analysis Systems, Inc. | 1978-11-03 |
| CPK REAGENT SET, NAD REDUCTION (K781719) | Medical Analysis Systems, Inc. | 1978-11-03 |
| REAGENT SET, U.V. ENZMATIC KINETIC, SGOT (K781725) | Medical Analysis Systems, Inc. | 1978-11-03 |
| REAGENT SET, CHOLESTEROL (K781721) | Medical Analysis Systems, Inc. | 1978-11-03 |
| NAD REDUCTION METHOD, LACTATE PYRIVATE (K781724) | Medical Analysis Systems, Inc. | 1978-11-03 |
| ALP REAGENT SET, ALKALINE PHOSPHATASE (K781718) | Medical Analysis Systems, Inc. | 1978-11-03 |
| SRD-2 (K781646) | Dynatech Laboratories, Inc. | 1978-10-27 |
| RIA KIT, LH (K781685) | Amersham Corp. | 1978-10-27 |
| AUTODILUTER 2 (K781645) | Dynatech Laboratories, Inc. | 1978-10-27 |
| SERI-SEP SERUM/PLASMA ISLOLATOR (K781629) | Wako Intl., Inc. | 1978-10-27 |
| L-CYSTEINE HYDROCHLORIDE (K781690) | Fisher Scientific Co., LLC | 1978-10-27 |
| BILIRUBIN DETERMINTAITON IN SERUM (K781610) | Fisher Scientific Co., LLC | 1978-10-24 |
| ALKALINE PHOSPHATASE IN SERUM (K781609) | Fisher Scientific Co., LLC | 1978-10-24 |
| CHOLESTEROL DET. IN SERUM (K781611) | Fisher Scientific Co., LLC | 1978-10-24 |
| RIA CONTROLS (K781593) | Dade, Baxter Travenol Diagnostics, Inc. | 1978-10-17 |
| RIA DIAG. TEST KIT FOR INDEXING THYROX. (K781560) | Nuclear Diagnostics, Inc. | 1978-10-17 |
| I-ESTRIOL TEST SET (K781599) | Wien Laboratories, Inc. | 1978-10-17 |
| RAD-291 (K781554) | Organon, Inc. | 1978-10-11 |
| EARLY PREGNANCY DETECTION KIT (K781487) | Radioassay Systems Laboratories, Inc. | 1978-10-11 |
| BCG ALBUMIN REAGET (K781441) | Analytical & Research Chemicals, Inc. | 1978-10-10 |
| RIA QUANT B-HCG TEST KIT (K781578) | Mallinckrodt Critical Care | 1978-10-10 |
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