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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
62
Latest Decision
1982-09-14

Clearances · page 107 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K822469 PSI CALCIUM REAGENT Pointe Scientific, Inc., CIC Class II 1982-09-14
K822468 PSI TOTAL PROTEIN REAGENT Pointe Scientific, Inc., CEK Class II 1982-09-14
K822288 LH (125I) RADIOIMMUNOASSAY Corning Medical & Scientific CEP Class I 1982-09-13
K822399 LEECO T4 QUANT DIAGNOSTICS TEST KIT Leeco Diagnostics, Inc. CDX Class II 1982-09-13
K822334 BILIRUBIN CALIBRATORS Gilford Diagnostics JIT Class II 1982-09-02
K822298 DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI Nuclear Medical Laboratories, Inc. JFH Class II 1982-09-02
K822152 HCG BETA RIA KIT Clinetics Corp. JHI Class II 1982-09-02
K822323 ULTRACHEM BUN-UV, 65080 & 65081 Harleco Diagnostics CDW Class II 1982-09-02
K822343 B-HCG Diagnostic Products Corp. JHI Class II 1982-09-02
K822422 BASIC CENTRIFUGE Biodynamics Corp. JQC Class I 1982-09-02
K822050 STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO Helena Laboratories JJQ Class I 1982-08-27
K822312 RAICHEM LDH-L REAGENT Reagents Applications, Inc. CFJ Class II 1982-08-27
K822381 SYVA LAB PROCESSOR 6000 Syva Co. JQP Class I 1982-08-27
K822208 CAVRO IQ-190 SAMPLE PROCESSOR Cavro Scientific Instruments, Inc. JQW Class I 1982-08-27
K822291 QUANTIMUNE HTSH IRMA Bio-Rad JLW Class II 1982-08-27
K822289 CO2/CI STANDARDS Gilford Diagnostics JIX Class II 1982-08-24
K822293 IMMU-COUNT 404 Kemble Instruments, Inc. JJJ Class I 1982-08-24
K822232 ACA URINARY PROTEIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIS Class II 1982-08-16
K822332 C-REACTIVE PROTEIN TEST KIT Sclavo, Inc. JIS Class II 1982-08-16
K822227 IMMO PHASE FSH RADIOIMMUNOASSAY Corning Medical & Scientific CGJ Class I 1982-08-16
K821982 TITAN GEL SERUM CONTROL Helena Laboratories JJY Class I 1982-08-16
K822237 UREA NITROGEN REAGENT SET (MOD. BERTHEL Sterling Biochemical, Inc. CDL Class II 1982-08-16
K822149 GILCHEM Y-GT REAGENT Gilford Diagnostics JPZ Class I 1982-08-12
K821026 BI-LEVEL ASSAYED TUMOR MARKER & ANTIN Ortho Diagnostic Systems, Inc. JJY Class I 1982-08-10
K822132 DADE CHILL TRAY American Dade JRR Class I 1982-08-05
K822154 UREA NITROGEN (ENZYMATIC) DETERMINATION The Dow Chemical Co. CDN Class II 1982-08-05
K822146 CORNING 101 PRINTER Corning Medical & Scientific JQP Class I 1982-08-05
K822121 ACRO PACK Gelman Sciences, Inc. JRL Class I 1982-08-05
K822140 IMMUCHEM COVALENT-COAT Immuchem Corp. JKC Class I 1982-08-05
K822133 IGE/THE OPHYLLINE CONTROL SERUM I,II,III Kallestad Laboratories, Inc. JJY Class I 1982-08-03
K822079 ENZYMATIC CO2 American Monitor Corp. KHS Class II 1982-07-27
K822078 DADE DISP. DISPENSING-SPREADING PIPETS American Dade JRC Class I 1982-07-27
K821944 TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT Hybritech, Inc. JHI Class II 1982-07-22
K821931 ZETA-CORT Amf Biological and Diagnostics Co. CGR Class II 1982-07-22
K821981 TITAN GEL CPK/LDH ISOENZYME CONTROL Helena Laboratories JJT Class I 1982-07-22
K821212 UREA NITROGEN REAGENT SET Omega Medical Electronics CDW Class II 1982-07-22
K821204 GLUCOSE(ENZYMATIC) REAGENT SET Omega Medical Electronics CGA Class II 1982-07-22
K821964 125I QUICK-MB TEST KIT FOR QUANTITATION Intl. Immunoassay Laboratories, Inc. JHT Class II 1982-07-22
K821206 SGPT-UV REAGENT SET Omega Medical Electronics CKA Class I 1982-07-22
K821201 LDH-UV REAGENT SET Omega Medical Electronics CFJ Class II 1982-07-20
K821205 TRIGLYCERIDE REAGENT SET Omega Medical Electronics CDT Class I 1982-07-20
K821946 ALT ENZYME ASSAY KIT Travenol Laboratories, S.A. CKA Class I 1982-07-20
K821905 BIURET (COLORIMETRIC) TOTAL PROTEIN American Monitor Corp. CEK Class II 1982-07-20
K821934 BIO-CAL OPERATION CHECK KIT Bio-Analytics Laboratories, Inc. JIS Class II 1982-07-20
K821208 SGOT-UV REAGENT SET Omega Medical Electronics CIT Class II 1982-07-20
K821937 SYVA ADVANCE STANDARDIZATION KIT #2 Syva Co. JIS Class II 1982-07-16
K821938 SYVA ADVANCE STANDARDIZATION KIT #3 Syva Co. JIS Class II 1982-07-16
K821676 PREG-PHILE B Bio Diagnostic Systems, Inc. JHJ Class II 1982-07-16
K821873 ULTRACHEM T-BILI Harleco Diagnostics CIG Class II 1982-07-14
K821880 ULTRA CHEM ALB Harleco Diagnostics CIX Class II 1982-07-14
K821879 ULTRACHEM T.P. Harleco Diagnostics CEX Class II 1982-07-14
K821877 ULTRAZYME PLUS HBD Harleco Diagnostics JMK Class I 1982-07-14
K821209 SGOT REAGENT SET Omega Medical Electronics CIQ Class II 1982-07-14
K821878 ULTRAZYME PLUS LDH Harleco Diagnostics CFJ Class II 1982-07-14
K821871 ULTRAZYME PLUS 2GT Harleco Diagnostics JPZ Class I 1982-07-14
K821207 SGPT REAGENT SET Omega Medical Electronics CKD Class I 1982-07-14
K821881 ULTRACHEM CREA Harleco Diagnostics CGX Class II 1982-07-14
K821872 ULTRACHEM URIC ACID AIDH Harleco Diagnostics CDO Class I 1982-07-14
K821883 ULTRAZYME PLUS CK-I Harleco Diagnostics CGS Class II 1982-07-14
K821882 ULTRAZYME PLUS GPT Harleco Diagnostics CKA Class I 1982-07-14
K821560 LEVEL II LIPID CONTROL Irvine Scientific JJY Class I 1982-07-13
K821657 RIAGEN B-HCG RIA Biogenex Laboratories JHI Class II 1982-07-13
K821198 DIRECT GLUCOSE REAGENT SET Omega Medical Electronics CGE Class II 1982-07-13
K821203 HDL PRECIPITANT REAGENT SET Omega Medical Electronics LBR Class I 1982-07-13
K821200 ALKALINE PHOSPHOTASE REAGENT SET Omega Medical Electronics CIO Class II 1982-07-13
K821874 ULTRACHEM PHOS Harleco Diagnostics CEO Class I 1982-07-13
K821559 LEVEL I LIPID CONTROL Irvine Scientific JJY Class I 1982-07-13
K821870 ULTRAZYME PLUS ALP Harleco Diagnostics CJE Class II 1982-07-13
K821869 ULTRAZYME PLUS AMYL Harleco Diagnostics JFJ Class II 1982-07-13
K821196 SERUM CALCIUM REAGENT SET Omega Medical Electronics CIC Class II 1982-07-13
K821335 GEMSTAR SYSTEM Electro-Nucleonics Laboratories, Inc. JJE Class I 1982-07-13
K821885 REF. ELECTRODE SOL'N.;STANDARD B Avl Scientific Corp. JIX Class II 1982-07-13
K821197 TOTAL BILIRUBIN REAGENT SET Omega Medical Electronics CIG Class II 1982-07-13
K821195 CHOLESTEROL REAGENT SET Omega Medical Electronics CHD Class I 1982-07-13
K821199 CREATININE REAGENT SET Omega Medical Electronics CGX Class II 1982-07-13
K821210 SERUM TOTAL PROTEIN REAGENT SET Omega Medical Electronics CEK Class II 1982-07-13
K821876 ULTRAZYME PLUS GOT Harleco Diagnostics CIT Class II 1982-07-13
K821892 PHILLIPS RADIATION MEASURING INSTRUMENT Long Island Scientific JJJ Class I 1982-07-13
K820666 HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. Immuno Nuclear Corp. JKD Class I 1982-07-13
K821213 URIC ACID REAGENT SET Omega Medical Electronics CDH Class I 1982-07-13
K821193 ALBUMIN REAGENT SET Omega Medical Electronics CIX Class II 1982-07-13
K821875 ULTRACHEM TRI-ES Harleco Diagnostics CDT Class I 1982-07-13
K821557 LEVEL I CONTROL SERUM Irvine Scientific JJY Class I 1982-07-08
K821861 COAT-A-COUNT INSULIN KIT Diagnostic Products Corp. CFP Class I 1982-07-08
K821868 ULTRACHEM E-GLU Harleco Diagnostics CFR Class II 1982-07-08
K821867 ULTRACHEM GLUC-DH Harleco Diagnostics LFR Class II 1982-07-06
K821738 CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST Miles Laboratories, Inc. KQO Class I 1982-07-06
K821741 URICACID Biodynamics Corp. KNK Class I 1982-07-02
K821805 PYRIDOXAL-5-PHOSPHATE STRIPES Boehringer Mannheim Corp. CKA Class I 1982-07-02
K821558 LEVEL II CONTROL SERUM Irvine Scientific JJX Class I 1982-07-02
K821822 MODEL 1020 NA/K ANALYZER Thermo Orion CEM Class II 1982-07-02
K821794 NOVA V FLUIDS PACK & EXTERNAL STANDARDS Shaban Mfg. Co. JIX Class II 1982-07-02
K821812 BECKMAN URIC ACID REAGENT Beckman Instruments, Inc. KNK Class I 1982-07-02
K821807 AMERIFLOUR FLUOROMETER American Diagnostic Corp. JQP Class I 1982-07-02
K821742 POSITIVE & NEGATIVE HCG URINE CONTROLS Armkel, LLC JJX Class I 1982-07-02
K821813 BECKMAN URIC ACID STANDARD Beckman Instruments, Inc. JIS Class II 1982-07-02
K821553 ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT Amf Biological and Diagnostics Co. KHQ Class II 1982-06-25
K821475 ULTRACHEM E-GLU #64976&65040 Emd Chemicals, Inc. CFR Class II 1982-06-25
K821554 ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT Amf Biological and Diagnostics Co. CDX Class II 1982-06-25
K821756 IEC CENTRA 4 CENTRIFUGE International Equipment Co. JQC Class I 1982-06-25

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