meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
59
Latest Decision
1990-08-22

Clearances · page 68 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K902909 CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL Creative Laboratory Products, Inc. JJY Class I 1990-08-22
K903333 CREATINE KINASE TEST (CK) ITEM NUMBER 65411 Em Diagnostic Systems, Inc. CGS Class II 1990-08-17
K903332 SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404 Em Diagnostic Systems, Inc. JFJ Class II 1990-08-17
K903225 CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT Medical Analysis Systems, Inc. JJY Class I 1990-08-17
K903190 MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY Medical Analysis Systems, Inc. JJY Class I 1990-08-17
K903335 SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 Em Diagnostic Systems, Inc. CDO Class I 1990-08-17
K903296 SYNERMED CREATININE REAGENT KIT Synermed, Inc. CGX Class II 1990-08-17
K896224 COBAS READY CALCIUM REAGENT Roche Diagnostic Systems, Inc. CIC Class II 1990-08-17
K903197 ASPARTATE AMINOTRANSFERASE TEST Em Diagnostic Systems, Inc. CIT Class II 1990-08-17
K902720 AFFINITY HCG TEST SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic JHI Class II 1990-08-09
K903147 CHEM-CHEX-ALT Streck Laboratories, Inc. JJX Class I 1990-08-09
K902569 PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF Boehringer Mannheim Corp. JJX Class I 1990-08-09
K903025 ROCHE ISOMUNE- CK Roche Diagnostic Systems, Inc. JHS Class II 1990-08-09
K903103 SYNERMED CHLORIDE REAGENT KIT Synermed, Inc. CHG Class II 1990-08-09
K902098 CHOLESTEROL (RATE) REAGENT Sigma Chemical Co. CHH Class I 1990-08-09
K903164 EURAMARK 610 PHOTOMETER Euro-American Marketing Group, Inc. JJQ Class I 1990-08-09
K902748 SEROZYME FREE T3 IMMUNOASSAY Advanced Magnetics, Inc. KHQ Class II 1990-08-09
K902681 EZ-SCREEN:HCG Environmental Diagnostics, Inc. JHI Class II 1990-08-09
K901449 VACUTAINER PLUS WITH HEMOGARD CLOSURE Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1990-08-09
K902568 REFLOTRON HDL CHOLESTEROL TEST TABS Boehringer Mannheim Corp. LBR Class I 1990-08-09
K901981 ABBOTT MODIFIED FACT PLUS PREGNANCY TEST Abbott Laboratories LCX Class II 1990-08-02
K902443 LUMATAG(TM) LH DIAGNOSTIC KIT London Diagnostics, Inc. CEP Class I 1990-08-02
K902776 SPECTROPHOTOMETER (MICROASSAY PLATE READERS) Slt Labinstruments, Inc. JJQ Class I 1990-07-31
K902202 DMA TRIGLYCERIDE (GPO) PROCEDURE Data Medical Associates, Inc. JGY Class I 1990-07-31
K902675 MULTI ANALYTE MIXTURE, CALIBRATORS Phoenix Diagnostics, Inc. JIX Class II 1990-07-31
K902326 AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. JFJ Class II 1990-07-31
K902174 COULTER HDL - CHOLESTEROL REAGENT Coulter Corp. LBR Class I 1990-07-31
K901042 IONOMETER EF-HK AND ACCESSORIES Fresenius USA, Inc. JGS Class II 1990-07-31
K902919 SYNERMED MAGNESIUM REAGENT KIT Synermed, Inc. JGJ Class I 1990-07-31
K902918 SYNERMED SERUM IRON REAGENT KIT Synermed, Inc. CFM Class I 1990-07-31
K902797 OPUS TM T-UPTAKE TEST SYSTEM Pb Diagnostic Systems, Inc. KHQ Class II 1990-07-30
K903016 SYNERMED TRIGLYCERIDES REAGENT KIT Synermed, Inc. CDT Class I 1990-07-27
K902877 TOTAL IRON FOR MANUAL/AUTOMATED Catachem, Inc. JIY Class I 1990-07-27
K902760 AMERSHAM TSH CONTROL SERA Amersham Corp. JJX Class I 1990-07-27
K902709 SECUTAINER Preserve JKA Class II 1990-07-27
K902922 MICROZYME T4 ENZYME IMMUNOASSAY KIT Immunotech Corp. CDX Class II 1990-07-27
K901900 L.D.X LIPID MONITORING SYSTEM Cholestech Corp. CHH Class I 1990-07-24
K901829 BEHRING CHROMOTIMER Behring Diagnostics, Inc. JJQ Class I 1990-07-24
K902094 BLOOD GAS/ISE CONTROLS Phoenix Diagnostics, Inc. JJY Class I 1990-07-19
K900087 GENESYS 6000 GAMMA COUNTER Laboratory Technologies, Inc. JJJ Class I 1990-07-19
K902592 EPC ELECTRONIC PIPETTING SYSTEM Ulster Scientific, Inc. JQW Class I 1990-07-19
K901527 BIURET (COLORMETRIC), TOTAL PROTEIN American Research Products Co. CEK Class II 1990-07-19
K901040 IONOMETER EH-F AND ACCESSORIES Fresenius USA, Inc. JGS Class II 1990-07-19
K902698 AFFINITY PROLACTIN TEST SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic CFT Class I 1990-07-19
K902616 BILIRUBIN CONTROL Phoenix Diagnostics, Inc. JJY Class I 1990-07-19
K902235 LVM QUALITY CONTROL SERUM Ciba Corning Diagnostics Corp. JJY Class I 1990-07-17
K902673 HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND Hi Chem, Inc. JJY Class I 1990-07-17
K902208 MODIFIED OVUGEN Biogenex Laboratories CEP Class I 1990-07-17
K901410 TECHNICON RA-2000(TM) SYSTEM Technicon Instruments Corp. JJC Class I 1990-07-17
K902560 ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT Roche Diagnostic Systems, Inc. CJE Class II 1990-07-17
K902801 BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT Beckman Instruments, Inc. CIG Class II 1990-07-17
K902476 CALCIUM:ARSENAZO III Amresco, Inc. CJY Class II 1990-07-17
K902479 CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 Amresco, Inc. CIC Class II 1990-07-17
K902867 CHEM-CHEX BILIRUBIN Streck Laboratories, Inc. JJX Class I 1990-07-16
K901711 PTH-MM II 125I RADIOIMMUNOASSAY (RIA) Incstar Corp. CEW Class II 1990-07-16
K902495 ACID PHOSPHATASE REAGENT SET Tech Intl. Co. CKB Class II 1990-07-16
K902699 SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY) Actio, Inc. JJW Class I 1990-07-16
K900733 PROTEIN TEST FOR URINE AND CSF Elite Technology, Inc. CEK Class II 1990-07-10
K902573 PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM Boehringer Mannheim Corp. JJY Class I 1990-07-10
K902689 ATAC 6000 CHEMISTRY ANALYZER Bio-Chem Laboratories JJE Class I 1990-07-10
K901613 MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM Medisense, Inc. CGA Class II 1990-07-10
K902753 IMX ULTRASENTITIVE HTSH Abbott Mfg., Inc. JLW Class II 1990-07-10
K902574 POTASSIUM REAGENT SET Tech-Co, Inc. CEJ Class II 1990-07-10
K902572 SODIUM REAGENT SET Tech Intl. Co. CEI Class II 1990-07-10
K902536 PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM Boehringer Mannheim Corp. JJY Class I 1990-07-10
K902483 CREATINE KINASE-MB TEST (MB-DS) ITEM #67655 Em Diagnostic Systems, Inc. CGS Class II 1990-07-10
K901500 CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA. Olympus Corp. CHJ Class II 1990-07-10
K900788 MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER Datachem, Inc. CEM Class II 1990-07-05
K902333 OPUS TSH TEST SYSTEM Pb Diagnostic Systems, Inc. JLW Class II 1990-07-05
K902294 ACCUSCAN MICROBEAD STANDARDS Sigma Chemical Co. JIW Class II 1990-07-03
K901039 IONOMETER EH Fresenius USA, Inc. CEM Class II 1990-06-28
K902321 HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) Hichem Diagnostics JJT Class I 1990-06-28
K902172 COULTER CREATININE REAGENT Coulter Corp. CGX Class II 1990-06-28
K902398 CIBA CORNING MAGIC LITE LH IMMUNOASSAY Ciba Corning Diagnostics Corp. CEP Class I 1990-06-28
K901933 COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 Diagnostic Products Corp. JFH Class II 1990-06-28
K902136 KODAK SURECELL(TM) HCG-URINE TEST KIT Eastman Kodak Company JHI Class II 1990-06-28
K902328 SYNERMED TOTAL BILIRUBIN REAGENT KIT Synermed, Inc. CIG Class II 1990-06-28
K901935 OPUS (TM) HCG Pb Diagnostic Systems, Inc. JHI Class II 1990-06-26
K896225 COBAS READY PROFILE 2 REAGENT STRIP Roche Diagnostic Systems, Inc. KNK Class I 1990-06-26
K897097 COBAS READY CALIBRATOR KIT Roche Diagnostic Systems, Inc. JIX Class II 1990-06-26
K901475 CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 Baxter Healthcare Corp CDX Class II 1990-06-20
K901041 IONOMETER EH-HK AND ACCESSORIES Fresenius USA, Inc. CEM Class II 1990-06-18
K902216 WAKO(TM) MICRO-ALBUMIN Wako Chemicals USA, Inc. JIQ Class I 1990-06-18
K902336 CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE Ciba Corning Diagnostics Corp. JJE Class I 1990-06-18
K902358 MODIFIED DELFIA ESTRADIOL KIT Pharmacia, Inc. CHP Class I 1990-06-18
K902175 COULTER UREA NITROGEN REAGENT Coulter Corp. CDQ Class II 1990-06-12
K902155 HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964) Hichem Diagnostics JIM Class II 1990-06-12
K902229 COULTER CARBON DIOXIDE REAGENT Coulter Corp. KHS Class II 1990-06-12
K902199 COULTER DIRECT BILIRUBIN Coulter Corp. CIG Class II 1990-06-12
K902173 COULTER SERUM IRON/UIBC REAGENT Coulter Corp. JIY Class I 1990-06-12
K902267 BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS Phoenix Diagnostics, Inc. CHL Class II 1990-06-12
K896467 SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM Medisense, Inc. CHH Class I 1990-06-12
K902095 BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS Phoenix Diagnostics, Inc. JJY Class I 1990-06-12
K901673 PROLACTIN (LACTOGEN) TEST SYSTEM Baxter Healthcare Corp CFT Class I 1990-06-12
K901858 MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST E.I. Dupont DE Nemours & Co., Inc. CET Class I 1990-06-12
K901463 REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) Helena Laboratories JQJ Class I 1990-06-12
K902266 ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) Phoenix Diagnostics, Inc. JJR Class I 1990-06-06
K901985 BLOOD GAS CONTROLS Phoenix Diagnostics, Inc. JJS Class I 1990-06-06
K902123 SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 Em Diagnostic Systems, Inc. CIG Class II 1990-06-06
K901960 IRON REAGENTS PRODUCT CODES 7725 AND 7726 American Research Products Co. JMO Class I 1990-05-31

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