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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ALBUMIN REAGENT SET (K832747)Biorent Diagnostic, Inc.1983-10-14
PARAMAX TOTAL BILIRUBIN REAGENT (K833004)American Dade1983-10-14
ENZYMUNE-TEST TSH (K832823)Icl Scientific1983-10-14
LIQUID CHROMATOGRAPH 1090 SERIES (K832375)Hewlett-Packard Co.1983-10-14
REFEREE BLOOD GAS ANALYZER-ELECTRODES (K832779)Analytical Products, Inc.1983-10-14
LIPASE HYDROLYSIS/GLYCEROL KINASE (K832871)Pointe Scientific, Inc.,1983-10-14
SERALYZER AST/SGOT REAGENT STRIPS (K832790)Miles Laboratories, Inc.1983-10-14
BLOOD GAS QUALITY CONTROL SOFT-86000F (K831574)Computermate, Inc.1983-10-14
EASYTOUCH BUN REAGENT SET (K832749)Worthington Diagnostic Systems1983-10-14
SHABAN #9852 CHIMNEY-#9854 SCREEN & (K832931)Shaban Mfg. Co.1983-10-14
SHABAN #9850 PUMP WINDINGS-9860 FILTER (K832936)Shaban Mfg. Co.1983-10-14
COMPUR* EASY TOUCH URIC ACID REAGENT (K832785)Worthington Diagnostic Systems1983-10-14
COMPUR* EASYTOUCH TOTAL BILIRUBIN (K832748)Worthington Diagnostic Systems1983-10-14
KEMTEK 400 RIA GAMMA COUNTER (K832734)Kemble Instruments, Inc.1983-10-14
VITAMIN B12 FOLATE CA-1515-125 (K832711)Clinical Assays, Inc.1983-10-04
SERALYZER TRIGLYCERIDES REAGENT STRIPS (K832684)Miles Laboratories, Inc.1983-10-04
FOLATE RADIOASSAY KIT CA-1562-125 (K832712)Clinical Assays, Inc.1983-10-04
LYPHOCHEK SERUM REF. STANDARD-BOVINE (K832695)Bio-Rad1983-10-04
QUICK-TELL INDIRECT PREGNANCY TEST (K832640)Stanbio Laboratory1983-10-04
VITAMIN B12 RADIOASSAY KIT CA-1534 (K832710)Clinical Assays, Inc.1983-10-04
ENCORE CHEMISTRY ANALYZER (K832716)Baker Instructions Corp.1983-10-04
KEMTEK 104 RIA GAMMA COUNTER (K832736)Kemble Instruments, Inc.1983-09-29
KEMTEK 103 RIA GAMMA COUNTER (K832735)Kemble Instruments, Inc.1983-09-29
INTRINSIC FACTOR BLOCKING ANTIBODY KIT (K832726)Diagnostic Products Corp.1983-09-29
DIAZO COLORIMETRY, BILLIRUBIN (K832870)Pointe Scientific, Inc.,1983-09-26
POTASSIUM TEST KIT (K832553)Mallinckrodt Critical Care1983-09-20
SODIUM TEST KIT (K832552)Mallinckrodt Critical Care1983-09-20
EPSILON TSH TEST KIT (K831972)Beckman Instruments, Inc.1983-09-20
EARLY IN HOME PREGNANCY TEST (K832599)Warner-Lambert Co.1983-09-20
ACCLAIM (K832648)Electro-Nucleonics Laboratories, Inc.1983-09-20
TRIGLYCERIDE REAGENT-TRINDER-GPO (K832460)Seppim, Inc.1983-09-12
EASYTOUCH TRIGLYCERIDES REAGENT SET (K832426)Worthington Diagnostic Systems1983-09-12
CREATINE KINASE REAGENT CK LTS (K831965)Electro-Nucleonics Laboratories, Inc.1983-09-12
SERUM HCG ASSAY (K832562)Monoclonal Antibodies, Inc.1983-09-12
ANDROSTENEDIONE TEST SET 125I (K832452)Wien Laboratories, Inc.1983-09-12
FERTITELL DIRECT PREGNANCY TEST #1100 (K832557)Stanbio Laboratory1983-09-12
ALBUMIN PROCEDURE BCP (K832632)Sandare Chemical Co., Inc.1983-09-12
T3-RIA SINGLE REAGENT (K832469)Fairlake Laboratories1983-09-12
AUTOPAK NEONATAL TSH RIA KIT (K832462)Micromedic Systems1983-09-12
ALT -LTS (K832639)Electro-Nucleonics Laboratories, Inc.1983-09-12
CORTISOL RADIOIMMUNOASSAY KIT (K832638)Bioclinical Group1983-09-12
RAICHEM ALKALINE PHOSPHATASE REAGENT (K832463)Reagents Applications, Inc.1983-09-12
PHASE II TSH KIT (K832499)Medical & Scientific Designs, Inc.1983-09-12
TUBING KIT 446 (K832584)Shaban Mfg. Co.1983-09-12
DEPROTEINIZING & CLEANING SOLUTION (K832415)Shaban Mfg. Co.1983-09-12
T4-RIA SINGLE REAGENT (K832468)Fairlake Laboratories1983-09-12
PREGNA-TEC (K832527)Medilab Corp.1983-09-12
DIASTIX REAGENT STRIPS FOR URINALYSIS (K831600)Miles Laboratories, Inc.1983-09-08
HYDROXYPROGESTERONE-17 (K832297)Diagnostics Biochem Canada, Inc.1983-09-01
DAC-CEL HCG-MCA KIT RD52 (K831073)Wellcome Diagnostics1983-09-01
ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK (K832357)E.I. Dupont DE Nemours & Co., Inc.1983-09-01
CORNING MAGIC SINGLE STEP FREE T4 (K832381)Corning Medical & Scientific1983-09-01
MAGIC TSH 125I RADIOIMMUNOASSAY (K832313)Corning Medical & Scientific1983-09-01
CARDIZYME PLUS LD #65094/93 (K832314)Em Industries, Inc.1983-09-01
ENZYMATIC TRIGLYCERIDES #2000 (K832444)Stanbio Laboratory1983-08-31
SIGMA PROCEDURE #550 DETERM. BILIRUB (K832236)Sigma Chemical Co.1983-08-31
HYBRITECH 405-500 NM FILTER MODULE (K832397)Hybritech, Inc.1983-08-31
CORNING'S MAGIC T3(125I) RADIOIMMUNO- (K832353)Corning Medical & Scientific1983-08-31
RAICHEM ACID PHASPHATASE REAGENT (K831834)Reagents Applications, Inc.1983-08-26
PHOTON IMMUNOASSAY ANALYZER (K832364)Hybritech, Inc.1983-08-26
IMMOBILINE SYSTEM LKB 1819 (K830797)Lkb Instruments, Inc.1983-08-24
HS-100 HEADSPACE SAMPLING ACCESSORY (K831387)The Perkin-Elmer Corp.1983-08-24
SPECTROPHOTOMETER #390 (K832206)Abbott Diagnostics1983-08-24
ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO (K831670)Ortho Diagnostic Systems, Inc.1983-08-24
SANDARE CALCIUM PROCEDURE (K832183)Sandare Chemical Co., Inc.1983-08-24
PRECISET CHOLESTEROL HIGH PERFORM (K832251)Boehringer Mannheim Corp.1983-08-24
PB 600 REPEATING DISPENSER (K832202)Hamilton Co.1983-08-24
THERMOMIXER S213-PHOTOANALYZER S263 (K831649)Texas Intl. Laboratories, Inc.1983-08-24
PRECISION LIQUID DISPENSER (K832205)Hamilton Co.1983-08-24
MICROLAB P (K832204)Hamilton Co.1983-08-24
GAMMA PHOTON GAMMA COUNTER (K832210)Medical & Scientific Designs, Inc.1983-08-24
KINETI COUNT 24 GAMMA COUNTER (K832209)Medical & Scientific Designs, Inc.1983-08-24
CHROM-PREP (K832201)Hamilton Co.1983-08-16
TOTAL PROTEIN PROCEDURE (K832169)Sandare Chemical Co., Inc.1983-08-16
FITKIT I CHECKUP KIT (K821799)Patton, Boggs & Blow1983-08-16
CHOLESTEROL HIGH PERFORMANCE-K (K832158)Boehringer Mannheim Corp.1983-08-16
DHEA-SULFATE I RIA KIT (K832154)Diagnostic Systems Laboratories, Inc.1983-08-16
PRP-1 REVERSED PHASE COLUMNS FOR HPLC (K832200)Hamilton Co.1983-08-16
GAMMA SLIDE TEST FOR PREGNANCY (K832473)Gamma Biologicals, Inc.1983-08-16
UNITIZED ENZYMATIC GLUCOSE TEST SET (K832159)Stanbio Laboratory1983-08-16
FITKIT I CHECKUP KIT (K830340)Boditestor1983-08-16
HC40/HC75 CATION EXCHANGE RESIN (K832199)Hamilton Co.1983-08-16
AMRESCO NA/K REAGENT SET (K832070)American Research Products Co.1983-08-12
TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY (K832139)Hybritech, Inc.1983-08-12
LIPASE REAGENT SET (K831874)Sterling Biochemical, Inc.1983-08-12
URINE TOTAL PROTEIN CONTROL (K831526)Quantimetrix Corp.1983-08-12
PRP-1 REVERSED PHASE RESIN (K832197)Hamilton Co.1983-08-12
HC40/HC75 PREPACKED COLUMS (K832198)Hamilton Co.1983-08-12
SERALYZER MULTICOMPONENT CALIBRATORS (K832046)Miles Laboratories, Inc.1983-08-11
WAKO CPK TEST (K832004)Wako Chemicals USA, Inc.1983-08-11
MAGIC TM 125I T3 UPTAKE RADIOASSAY (K831613)Corning Medical & Scientific1983-08-11
TOTAL CO2 REAGENT SET (K832071)American Research Products Co.1983-08-11
UCG-BETA SLIDE MONOCLONAL (K831775)Armkel, LLC1983-08-11
BILIRUBIN CALIBRATORS & CONTROL (K832094)Gilford Diagnostics1983-08-11
AQUEOUS BLOOD GAS CONTROL LEVEL I,II & (K832003)American Dade1983-08-10
STAT-TRAK LIQUID ELECTROLYTE CONTROL (K831389)United Diagnostics, Inc.1983-08-10
DATA-ZYME URIC ACID PROCEDURE (K831983)Data Medical Associates, Inc.1983-08-08
BIOCHECK POSITIVE URINE CONTROL (K831994)Helena Laboratories1983-08-08
NML-5010/5020 MULTI-DETECTOR SYSTEM (K832002)Nuclear Medical Laboratories, Inc.1983-08-08
VISIDEX II REAGENT STRIPS (K831989)Miles Laboratories, Inc.1983-08-08
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