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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
61
Latest Decision
1983-10-28

Clearances · page 102 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K832892 MODIFIED CHORIO-SHURE Nuclear Medical Laboratories, Inc. JHI Class II 1983-10-28
K832809 ACCU-PREP PROGRAMMABLE AUTO-DILUTER Beckman Instruments, Inc. JQW Class I 1983-10-27
K832164 COAT-A-COUNT FREE T3 RIA KIT Diagnostic Products Corp. CDP Class II 1983-10-27
K833247 QUANTAPHASE B-12-COBALMIN-FOLATE- Bio-Rad CDD Class II 1983-10-19
K833004 PARAMAX TOTAL BILIRUBIN REAGENT American Dade CIG Class II 1983-10-14
K832747 ALBUMIN REAGENT SET Biorent Diagnostic, Inc. CIX Class II 1983-10-14
K832823 ENZYMUNE-TEST TSH Icl Scientific JLW Class II 1983-10-14
K832760 RIA SOFTWARE Kemble Instruments, Inc. JQP Class I 1983-10-14
K832785 COMPUR* EASY TOUCH URIC ACID REAGENT Worthington Diagnostic Systems KNK Class I 1983-10-14
K832708 PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS American Dade CIC Class II 1983-10-14
K832734 KEMTEK 400 RIA GAMMA COUNTER Kemble Instruments, Inc. JJJ Class I 1983-10-14
K833001 PARAMAX & GLUTAMYTRANSFERASE REAGENT American Dade JQB Class I 1983-10-14
K832780 FLOW-PAC SHOLESTEROL REAGENT SET American Research Products Co. CHH Class I 1983-10-14
K832748 COMPUR* EASYTOUCH TOTAL BILIRUBIN Worthington Diagnostic Systems CIG Class II 1983-10-14
K832375 LIQUID CHROMATOGRAPH 1090 SERIES Hewlett-Packard Co. LDM Class I 1983-10-14
K832790 SERALYZER AST/SGOT REAGENT STRIPS Miles Laboratories, Inc. CIF Class II 1983-10-14
K832931 SHABAN #9852 CHIMNEY-#9854 SCREEN & Shaban Mfg. Co. JJO Class I 1983-10-14
K833002 PARAMAX PHOSPHORUS REAGENT American Dade CEO Class I 1983-10-14
K832871 LIPASE HYDROLYSIS/GLYCEROL KINASE Pointe Scientific, Inc., CDT Class I 1983-10-14
K832779 REFEREE BLOOD GAS ANALYZER-ELECTRODES Analytical Products, Inc. CHL Class II 1983-10-14
K832872 HEXOKINASE, GLUCOSE Pointe Scientific, Inc., CFR Class II 1983-10-14
K832791 SERAYZER ALT/SGPT REAGENT STRIPS Miles Laboratories, Inc. CKC Class I 1983-10-14
K832936 SHABAN #9850 PUMP WINDINGS-9860 FILTER Shaban Mfg. Co. JJO Class I 1983-10-14
K831574 BLOOD GAS QUALITY CONTROL SOFT-86000F Computermate, Inc. JQP Class I 1983-10-14
K832759 TOTAL IRON-BINDING CAPACITY ACCESORY Seragen Diagnostics, Inc. JMO Class I 1983-10-14
K832937 SHABAN #9868 TUBING KIT-9870 STYLET Shaban Mfg. Co. JJO Class I 1983-10-14
K832749 EASYTOUCH BUN REAGENT SET Worthington Diagnostic Systems CDQ Class II 1983-10-14
K832932 SHABAN #9858 ASPIRATOR ASSEMBLE #9862- Shaban Mfg. Co. JJO Class I 1983-10-14
K832710 VITAMIN B12 RADIOASSAY KIT CA-1534 Clinical Assays, Inc. CDD Class II 1983-10-04
K832716 ENCORE CHEMISTRY ANALYZER Baker Instructions Corp. JJG Class I 1983-10-04
K832695 LYPHOCHEK SERUM REF. STANDARD-BOVINE Bio-Rad JIX Class II 1983-10-04
K832640 QUICK-TELL INDIRECT PREGNANCY TEST Stanbio Laboratory JHJ Class II 1983-10-04
K832684 SERALYZER TRIGLYCERIDES REAGENT STRIPS Miles Laboratories, Inc. CDT Class I 1983-10-04
K832712 FOLATE RADIOASSAY KIT CA-1562-125 Clinical Assays, Inc. CGN Class II 1983-10-04
K832711 VITAMIN B12 FOLATE CA-1515-125 Clinical Assays, Inc. CDD Class II 1983-10-04
K832735 KEMTEK 103 RIA GAMMA COUNTER Kemble Instruments, Inc. JJJ Class I 1983-09-29
K832736 KEMTEK 104 RIA GAMMA COUNTER Kemble Instruments, Inc. JJJ Class I 1983-09-29
K832726 INTRINSIC FACTOR BLOCKING ANTIBODY KIT Diagnostic Products Corp. CDD Class II 1983-09-29
K832870 DIAZO COLORIMETRY, BILLIRUBIN Pointe Scientific, Inc., CIG Class II 1983-09-26
K832553 POTASSIUM TEST KIT Mallinckrodt Critical Care CEJ Class II 1983-09-20
K832599 EARLY IN HOME PREGNANCY TEST Warner-Lambert Co. JHJ Class II 1983-09-20
K831972 EPSILON TSH TEST KIT Beckman Instruments, Inc. JLW Class II 1983-09-20
K832648 ACCLAIM Electro-Nucleonics Laboratories, Inc. JJE Class I 1983-09-20
K832552 SODIUM TEST KIT Mallinckrodt Critical Care CEI Class II 1983-09-20
K832562 SERUM HCG ASSAY Monoclonal Antibodies, Inc. JHI Class II 1983-09-12
K832639 ALT -LTS Electro-Nucleonics Laboratories, Inc. CKA Class I 1983-09-12
K832638 CORTISOL RADIOIMMUNOASSAY KIT Bioclinical Group CGR Class II 1983-09-12
K832463 RAICHEM ALKALINE PHOSPHATASE REAGENT Reagents Applications, Inc. CJE Class II 1983-09-12
K832527 PREGNA-TEC Medilab Corp. JHJ Class II 1983-09-12
K832632 ALBUMIN PROCEDURE BCP Sandare Chemical Co., Inc. CJW Class II 1983-09-12
K832462 AUTOPAK NEONATAL TSH RIA KIT Micromedic Systems JLW Class II 1983-09-12
K831965 CREATINE KINASE REAGENT CK LTS Electro-Nucleonics Laboratories, Inc. CGS Class II 1983-09-12
K832426 EASYTOUCH TRIGLYCERIDES REAGENT SET Worthington Diagnostic Systems CDT Class I 1983-09-12
K832415 DEPROTEINIZING & CLEANING SOLUTION Shaban Mfg. Co. JGS Class II 1983-09-12
K832460 TRIGLYCERIDE REAGENT-TRINDER-GPO Seppim, Inc. JGY Class I 1983-09-12
K832557 FERTITELL DIRECT PREGNANCY TEST #1100 Stanbio Laboratory JHJ Class II 1983-09-12
K832499 PHASE II TSH KIT Medical & Scientific Designs, Inc. JLW Class II 1983-09-12
K832584 TUBING KIT 446 Shaban Mfg. Co. JJE Class I 1983-09-12
K832468 T4-RIA SINGLE REAGENT Fairlake Laboratories CDX Class II 1983-09-12
K832452 ANDROSTENEDIONE TEST SET 125I Wien Laboratories, Inc. CIZ Class I 1983-09-12
K832469 T3-RIA SINGLE REAGENT Fairlake Laboratories CDP Class II 1983-09-12
K831600 DIASTIX REAGENT STRIPS FOR URINALYSIS Miles Laboratories, Inc. JIL Class II 1983-09-08
K832381 CORNING MAGIC SINGLE STEP FREE T4 Corning Medical & Scientific CEC Class II 1983-09-01
K832357 ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK E.I. Dupont DE Nemours & Co., Inc. CIG Class II 1983-09-01
K832314 CARDIZYME PLUS LD #65094/93 Em Industries, Inc. CFE Class II 1983-09-01
K832297 HYDROXYPROGESTERONE-17 Diagnostics Biochem Canada, Inc. JLS Class I 1983-09-01
K832313 MAGIC TSH 125I RADIOIMMUNOASSAY Corning Medical & Scientific JLW Class II 1983-09-01
K831073 DAC-CEL HCG-MCA KIT RD52 Wellcome Diagnostics CFL Class I 1983-09-01
K832397 HYBRITECH 405-500 NM FILTER MODULE Hybritech, Inc. JJQ Class I 1983-08-31
K832444 ENZYMATIC TRIGLYCERIDES #2000 Stanbio Laboratory CDT Class I 1983-08-31
K832236 SIGMA PROCEDURE #550 DETERM. BILIRUB Sigma Chemical Co. CIG Class II 1983-08-31
K832353 CORNING'S MAGIC T3(125I) RADIOIMMUNO- Corning Medical & Scientific CDP Class II 1983-08-31
K832364 PHOTON IMMUNOASSAY ANALYZER Hybritech, Inc. JJQ Class I 1983-08-26
K831834 RAICHEM ACID PHASPHATASE REAGENT Reagents Applications, Inc. CKB Class II 1983-08-26
K832209 KINETI COUNT 24 GAMMA COUNTER Medical & Scientific Designs, Inc. JJJ Class I 1983-08-24
K832183 SANDARE CALCIUM PROCEDURE Sandare Chemical Co., Inc. CIC Class II 1983-08-24
K830797 IMMOBILINE SYSTEM LKB 1819 Lkb Instruments, Inc. JJN Class I 1983-08-24
K832205 PRECISION LIQUID DISPENSER Hamilton Co. JQW Class I 1983-08-24
K831387 HS-100 HEADSPACE SAMPLING ACCESSORY The Perkin-Elmer Corp. KZQ Class I 1983-08-24
K832210 GAMMA PHOTON GAMMA COUNTER Medical & Scientific Designs, Inc. JJJ Class I 1983-08-24
K832202 PB 600 REPEATING DISPENSER Hamilton Co. JQW Class I 1983-08-24
K832251 PRECISET CHOLESTEROL HIGH PERFORM Boehringer Mannheim Corp. JIS Class II 1983-08-24
K832204 MICROLAB P Hamilton Co. JQW Class I 1983-08-24
K831649 THERMOMIXER S213-PHOTOANALYZER S263 Texas Intl. Laboratories, Inc. JJE Class I 1983-08-24
K831670 ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO Ortho Diagnostic Systems, Inc. JFH Class II 1983-08-24
K832206 SPECTROPHOTOMETER #390 Abbott Diagnostics JJQ Class I 1983-08-24
K832201 CHROM-PREP Hamilton Co. KZR Class I 1983-08-16
K832169 TOTAL PROTEIN PROCEDURE Sandare Chemical Co., Inc. CEK Class II 1983-08-16
K832154 DHEA-SULFATE I RIA KIT Diagnostic Systems Laboratories, Inc. JKC Class I 1983-08-16
K830340 FITKIT I CHECKUP KIT Boditestor CDM Class I 1983-08-16
K832159 UNITIZED ENZYMATIC GLUCOSE TEST SET Stanbio Laboratory CGA Class II 1983-08-16
K832200 PRP-1 REVERSED PHASE COLUMNS FOR HPLC Hamilton Co. DPM Class I 1983-08-16
K821799 FITKIT I CHECKUP KIT Patton, Boggs & Blow CDM Class I 1983-08-16
K832473 GAMMA SLIDE TEST FOR PREGNANCY Gamma Biologicals, Inc. JHJ Class II 1983-08-16
K832158 CHOLESTEROL HIGH PERFORMANCE-K Boehringer Mannheim Corp. CHH Class I 1983-08-16
K832199 HC40/HC75 CATION EXCHANGE RESIN Hamilton Co. DNH Class I 1983-08-16
K831874 LIPASE REAGENT SET Sterling Biochemical, Inc. JGX Class I 1983-08-12
K831526 URINE TOTAL PROTEIN CONTROL Quantimetrix Corp. JJW Class I 1983-08-12
K832139 TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY Hybritech, Inc. JHY Class II 1983-08-12
K832197 PRP-1 REVERSED PHASE RESIN Hamilton Co. DMZ Class I 1983-08-12

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.