Clinical Chemistry
13,051 FDA 510(k) clearances · Medical specialty
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| Record | Firm | Date |
|---|---|---|
| ELECTROPHORESIS REAGENT SET, HDL (K790791) | Gelman Sciences, Inc. | 1979-06-15 |
| CHEMTAB (K790772) | Boehringer Mannheim Corp. | 1979-06-15 |
| CENTRIA T4 RIA TEST SET (K790800) | Ventrex Laboratories, Inc. | 1979-06-15 |
| OSMOMETER MODEL 3W11 (K790611) | Advanced Instruments, Inc. | 1979-06-15 |
| FETAL MATURITY TEST PROCEDURE (K790798) | Helena Laboratories | 1979-06-05 |
| EMIT CFA THYROXINE ASSAY (K790686) | Syva Co. | 1979-05-25 |
| RIA KIT, PROSTATIC ACID (K790580) | Monitor Science Corp. | 1979-05-25 |
| ESTRADIOL RIA KIT (K790679) | Serono Laboratories, Inc. | 1979-05-23 |
| ENZYMATIC DETERMINATION (K790724) | Sigma Chemical Co. | 1979-05-23 |
| WAKO CHOLESTEROL TEST (K790768) | Wako Intl., Inc. | 1979-05-23 |
| REAGENT SYSTEM #350HDL, SIGMA PROCEDURE (K790760) | Sigma Chemical Co. | 1979-05-23 |
| DATA-ZYME ACIA PHOSPHATASE PROCEDURE (K790524) | Data Medical Associates, Inc. | 1979-05-23 |
| CENTRIFICHEM FILTER CALIBRATION SET (K790643) | Union Carbide Corp. | 1979-05-23 |
| CONCEP-7-B-HCG (K790397) | Leeco Diagnostics, Inc. | 1979-05-23 |
| NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM (K790665) | Micromedic Systems | 1979-05-15 |
| ROCHE LACTATE ANALYZER 640 (K790421) | Roche Medical Electronics, Inc. | 1979-05-15 |
| CHROMATOGRAPHY TUBES (K790581) | Miles Laboratories, Inc. | 1979-05-15 |
| LD-P REAGENT (LDH P-L REAGENT) (K790771) | Gilford Diagnostics | 1979-05-15 |
| GAMMA SMAC REAGENTS (K790578) | Gamma Enterprises, Inc. | 1979-05-15 |
| CENTRIFICHEM INORGANIC PHOSPHORUS (K790662) | Union Carbide Corp. | 1979-05-15 |
| CENTRIA SYSTEM (K790550) | Union Carbide Corp. | 1979-05-07 |
| PAP RIA KIT (K790317) | Yang Laboratories, Inc. | 1979-05-07 |
| CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC (K790556) | Calbiochem-Behring Corp. | 1979-05-07 |
| RIA KIT, QUANTITATION OF PROSTATIC ACID (K790817) | New England Nuclear | 1979-05-07 |
| HEATING BLOCK, WAMPOLE 37 C (K790549) | Armkel, LLC | 1979-05-03 |
| H-D-EL (K790372) | General Diagnostics | 1979-05-03 |
| SPECTROPHOTOMETER SYSTEM, MODEL AA-475 (K790781) | Varian Assoc., Inc. | 1979-05-03 |
| THE ABBOTT EXECUTIVE (K790543) | Abbott Laboratories | 1979-05-03 |
| COULTER ACCU-ZYME II GOT REAGENT (K790483) | Coulter Electronics, Inc. | 1979-05-03 |
| AMYLOCHROME STAT SEPARATOR, TEST (K790485) | Hoffmann-La Roche, Inc. | 1979-05-03 |
| ATOMIC ABSORPTION SPECTROPHOTOMETER, (K790780) | Varian Assoc., Inc. | 1979-05-03 |
| T-3 UPTAKE (MAA) KIT (K790461) | Amersham Corp. | 1979-05-03 |
| THYROXINE RIA KIT (K790495) | Technia Diagnostics , Ltd. | 1979-05-03 |
| PROGESTERONE (K790440) | Serono Laboratories, Inc. | 1979-05-03 |
| SZAMYL 6.5 (K790474) | Worthington Diagnostic Systems | 1979-05-01 |
| DATA-ZYME CK CALORIMETRIC/UV PROCEDURE (K790343) | Data Medical Associates, Inc. | 1979-05-01 |
| COULTER ACCU-ZYME II GPT REAGENT (K790522) | Coulter Electronics, Inc. | 1979-05-01 |
| TY RIA KIT, AUTOMATED ASSAY SYSTEM (K790477) | E. R. Squibb & Sons, Inc. | 1979-04-26 |
| FLOZYME* URIC ACID REAGENT (K790486) | Worthington Diagnostic Systems | 1979-04-23 |
| T3 UPTAKE KIT (K790417) | E. R. Squibb & Sons, Inc. | 1979-04-20 |
| MULTISKAN (78-503-00) (K790422) | Flow Laboratories, Inc. | 1979-04-20 |
| P.A.P. TEST KIT, RIA-ZYME (K790040) | Mallinckrodt Critical Care | 1979-04-17 |
| A-GENT-HDL REAGENT (K790329) | Abbott Laboratories | 1979-04-04 |
| CPK-CS (K790357) | Hoffmann-La Roche, Inc. | 1979-04-04 |
| SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 (K782166) | Ortho Diagnostics, Inc. | 1979-04-04 |
| ANALYZER, CENTRIFUCHEM SYSTEM 400 (K790278) | Union Carbide Corp. | 1979-04-04 |
| UNION CARBIDE CORP. COMPUTER INTERFACE (K790336) | Union Carbide Corp. | 1979-04-04 |
| NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) (K790248) | Boehringer Laboratories | 1979-04-04 |
| CORTISOL RIA KIT (K790268) | E. R. Squibb & Sons, Inc. | 1979-04-04 |
| ATOMIZER, FURNACE MODEL HGA-400 (K790111) | The Perkin-Elmer Corp. | 1979-04-04 |
| PREGNANCY, SENSIDEX TUBE TEST (K782063) | Ortho Diagnostics, Inc. | 1979-04-04 |
| MACOMB LIPID CONTROL (K790371) | Macomb Chemical Co. | 1979-04-04 |
| DUPONT ACA CKMB VERIFIERS (K790376) | E.I. Dupont DE Nemours & Co., Inc. | 1979-04-04 |
| CPK ISOENZYME SUBSTRATE (K790309) | Electrophoresis Corp. | 1979-04-04 |
| LANCER ICE CUBE (K782077) | Sherwood Medical Industries | 1979-04-03 |
| SENSI-TEX (K790267) | Hoffmann-La Roche, Inc. | 1979-03-21 |
| NTSH AUTOPAK TEST DELIVERY SYSTEM (K790260) | Micromedic Systems | 1979-03-21 |
| BUFFER, CORNING MOPSO (K790294) | Corning Medical & Scientific | 1979-03-21 |
| DIAGNOSTIC SET, LIPO-FRAX (K790281) | Analytical Products, Inc. | 1979-03-21 |
| ORTHO-TOLUIDINE REAGENT SET (K790319) | Fisher Scientific Co., LLC | 1979-03-21 |
| SERUM PAK, HCG CONTROL (K790129) | Mallinckrodt Critical Care | 1979-03-21 |
| RIA SYSTEM, PARATHYROID HORMONE (K782081) | Iso-Tex Diagnostics | 1979-03-21 |
| LDH ISOENZYME REAGENT (K790311) | Electrophoresis Corp. | 1979-03-21 |
| DATA-TOPE TRI-RAC RADIOASSAY CONTROL (K790264) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-03-21 |
| AUTOSAMPLER, MODEL AS-40 (K790117) | The Perkin-Elmer Corp. | 1979-03-19 |
| SPECTROPHOTOMETER MODEL 3000 (K790235) | The Perkin-Elmer Corp. | 1979-03-15 |
| SPECTROPHOTOMETER MODEL 650-40 (K790236) | The Perkin-Elmer Corp. | 1979-03-15 |
| CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN (K790330) | Calbiochem-Behring Corp. | 1979-03-15 |
| REAGENT KIT, LANCER GLUCOSE (K790197) | Sherwood Medical Industries | 1979-03-12 |
| CHORIC-SHURE (K790138) | Nuclear Medical Laboratories, Inc. | 1979-03-12 |
| ACA CREATINE KINASE ISOENZYMES (K790088) | E.I. Dupont DE Nemours & Co., Inc. | 1979-03-12 |
| NEPHELOMETER, MIC-2000 LASER (K790103) | Dynatech Corp. | 1979-03-12 |
| RIA KIT, PROLACTIN (K790003) | Cis Radiopharmaceuticals, Inc. | 1979-03-12 |
| URIC ACID, BOUND ENZYME (K790092) | Technicon Instruments Corp. | 1979-03-12 |
| UNITEST AMYLASE (K782032) | Boehringer Mannheim Corp. | 1979-03-02 |
| RIA KIT, PROGESTERONE (K782009) | The Upjohn Co. | 1979-03-02 |
| SPINSEP-FE59 (K790133) | Nuclear Diagnostics, Inc. | 1979-03-02 |
| UNITEST CREATINE KINASE (K782156) | Boehringer Mannheim Corp. | 1979-03-02 |
| RIA KIT, VITAMIN B12 (K782024) | Technia Diagnostics , Ltd. | 1979-02-28 |
| HYCEL M (K790335) | Hycel, Inc. | 1979-02-27 |
| SERUM, GLUTAMIC-OXALOACETIC (K790017) | Fisher Scientific Co., LLC | 1979-02-26 |
| I ESTRIOL (K790008) | Cambridge Nuclear Corp. | 1979-02-26 |
| SERACON-N (K782039) | Bhp Diagnostix, Inc. | 1979-02-26 |
| SERUM, URIC ACID DETERMINATION (K790019) | Fisher Scientific Co., LLC | 1979-02-26 |
| IEC CENTRA-7 CENTRIFUGE MODEL 2362 (K782124) | Damon Corp. | 1979-02-26 |
| I TESTOTERONE (K790007) | Cambridge Nuclear Corp. | 1979-02-26 |
| ANALYZER, IMPACT 200 (K790072) | Gilford Instrument Laboratories, Inc. | 1979-02-22 |
| REAGENT KIT, BAKERS DIAGNOSTIC (K790044) | J.T. Baker Chemical Co. | 1979-02-22 |
| ANALYZER, IMPACT 100 (K790073) | Gilford Instrument Laboratories, Inc. | 1979-02-22 |
| ACCESSORY KIT, CENTRIFICHEM (K790041) | Union Carbide Corp. | 1979-02-22 |
| RIA KIT, GLUCOSE (K782143) | Serono Laboratories, Inc. | 1979-02-22 |
| REAGENT KIT, CHLORIDE/CARBON DIOXIDE (K790045) | J.T. Baker Chemical Co. | 1979-02-22 |
| ALKALINE PHOSPHATASE (K790065) | Macomb Chemical Co. | 1979-02-21 |
| SERUM, CREATININE PHOSPHOKINASE (K790015) | Fisher Scientific Co., LLC | 1979-02-15 |
| MINI-DILUTER 2 (K782130) | Dynatech Laboratories, Inc. | 1979-02-15 |
| CARTRIDGE HOLDER, RCM 100 (K782175) | Waters Assoc., Inc. | 1979-02-15 |
| SERUM, INORGANIC PHOSPHOROUS (K790021) | Fisher Scientific Co., LLC | 1979-02-15 |
| SERUM, GLUTAMIC-PYRUVIC (K790016) | Fisher Scientific Co., LLC | 1979-02-15 |
| SOLVENT DELIVERY SYSTEM (K790145) | Waters Assoc., Inc. | 1979-02-15 |
| SERACON-LP (K782170) | Bhp Diagnostix, Inc. | 1979-02-15 |
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