meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
57
Latest Decision
1984-01-24

Clearances · page 101 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K833992 TECHNICON RA-1000 SYSTEM Technicon Instruments Corp. JGS Class II 1984-01-24
K833925 COAT-A-COUNT NHS-PROLACTIN KIT AND Diagnostic Products Corp. CFT Class I 1984-01-24
K833406 IMMOPHASE D-TE 3 RADIOIMMUNOASSAY Corning Medical & Scientific CGF Class I 1984-01-24
K832438 CHLORIDE REAGENT SET Amresco, Inc. CHJ Class II 1984-01-20
K833781 DURAZYME CPK American Monitor Corp. CGS Class II 1984-01-18
K833137 ORTHO B-HCG SLIDE TEST FOR PREGNANCY Ortho Diagnostic Systems, Inc. JHJ Class II 1984-01-18
K833696 ACID BASE LABORATORY ABL4 Radiometer America, Inc. CEM Class II 1984-01-18
K833850 T4 RIA Syncor Intl. Corp. CDX Class II 1984-01-18
K833194 TANDEM R-TOTAL B-GCG KIT Hybritech, Inc. JHI Class II 1984-01-18
K833833 KODAK EKTACHEM 700 ANALYZER Eastman Kodak Company JJE Class I 1984-01-17
K832439 CREATININE REAGENT SET Amresco, Inc. CGX Class II 1984-01-17
K833804 SHABAN 9865 IL#78637 JUNCTION BLOC Shaban Mfg. Co. JJF Class I 1984-01-13
K833854 LH RIA Syncor Intl. Corp. CEP Class I 1984-01-13
K833009 OMNI-FAL I & II American Monitor Corp. JJY Class I 1984-01-13
K833666 UR/RITE SYSTEM Wright Laboratories, Inc. JQW Class I 1984-01-13
K833712 NA/K FLUIDA PACK FOR NOVA 1 ANALYZER Fisher Scientific Co., LLC JGS Class II 1984-01-13
K833852 FSH RIA Syncor Intl. Corp. CGJ Class I 1984-01-13
K833699 ALBUMIN REAGENT CS-716 Fisher Scientific Co., LLC CIX Class II 1984-01-13
K833898 TRI-LEVEL BILIRUBIN CONTROLS Sandare Chemical Co., Inc. JJX Class I 1984-01-13
K833744 ALKALINE PHOSPHATASE-RATE Seragen Diagnostics, Inc. CJE Class II 1984-01-13
K833431 HDL EX-SEP PRECIPITATING REAGENT Preventive Diagnostics Corp. LBR Class I 1984-01-13
K833864 AMYLASE REAGENT SET-MODIFIED CARAWAY Sterling Biochemical, Inc. CJA Class II 1984-01-13
K833746 TECH. RA-1000 SYS SERUM CHLORIDE Technicon Instruments Corp. CHJ Class II 1984-01-13
K833950 TOTAL PROTEIN REAGENT CS-724 Fisher Scientific Co., LLC CEK Class II 1984-01-13
K833931 UREA NITROGEN-UV Seragen Diagnostics, Inc. CDQ Class II 1984-01-13
K833097 CHEM TRAK LIQUID BILIRUBIN CONTROL Medical Analysis Systems, Inc. JJX Class I 1984-01-11
K833471 ADRENOCOR TICOTROPIC HORMONE RADIOIMM Nichols Institute Diagnostics CKG Class II 1984-01-11
K833505 IL MODEL 840 MICROPROCESSOR LOADER Instrumentation Laboratory CO JQW Class I 1984-01-11
K834150 STRIP SPLITTER II -HALF WIDTH CARRIER Larken Industries, Inc. JJQ Class I 1984-01-11
K832694 DIRIA-PROGK IMMUNOASSAY Sorin Biomedica, Fiat, USA, Inc. JLS Class I 1984-01-11
K832593 HOSPITAL LAB IN-HOME EARLY PREG TEST Aicl-Pack, Inc. LCX Class II 1984-01-11
K833521 REAGENT TESTS STRIP COMBINATIONS Syn-Kit, Inc. JJB Class I 1984-01-11
K832115 ATAC 3000 Turpen Laboratory Systems, Inc. JJE Class I 1984-01-10
K833504 PREGNASTICK URINE HCG KIT Monoclonal Antibodies, Inc. JHJ Class II 1984-01-09
K833639 TITANGEL HIGH RESOLUTION CONTROL Helena Laboratories JJY Class I 1984-01-04
K833745 RIACOAT T-4 Immuno Assay Corp. CDX Class II 1984-01-04
K833702 ACA THYROXINE UPTAKE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIT Class II 1984-01-04
K833535 POTASSIUM SODIUM ANALYSIS PRODUCTS Shaban Mfg. Co. JJO Class I 1983-12-29
K833932 SYVA ADVANCE CORTISOL ASSAY Syva Co. JFT Class II 1983-12-29
K833724 ENZYMATIC CO2 American Monitor Corp. CIL Class II 1983-12-29
K833768 C. PTH RADIOIMMUNOASSAY KIT-CPTHK Sorin Biomedica, Fiat, USA, Inc. CEW Class II 1983-12-29
K833776 QEA SODIUM/POTASSIUM ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic CEM Class II 1983-12-29
K833534 PARTIAL PRESSURE ELECTRODE MEASUREMENT Shaban Mfg. Co. CHL Class II 1983-12-29
K833713 SERUM THYROTROPIN ASSAY KIT, TIPSEP- Nuclear Diagnostics, Inc. JLW Class II 1983-12-29
K833536 PARTIAL PRESSURE ELECTRODE MEASUREMENT Shaban Mfg. Co. CHL Class II 1983-12-29
K833029 FLOW-PAC GGT REAGENT SET American Research Products Co. JQB Class I 1983-12-29
K833700 ACA THYROXINE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIT Class II 1983-12-27
K833448 EPOS CHEMISTRY ANALYZER 5060 & 6410 Emd Chemicals, Inc. JJE Class I 1983-12-22
K834007 CYSTINE TRYPTIC MEDIUM Micro Media Laboratories JSQ Class I 1983-12-22
K833353 ACLAIM-QAP IBM PERSONAL COMPUTER EDT American Dade JQP Class I 1983-12-22
K832713 IRI SPEC URINALYSIS CONTROL Intl. Remote Imaging Systems JJW Class I 1983-12-22
K833376 RIANEN LUTEINIZING HORMONE RIA KIT New England Nuclear CEP Class I 1983-12-20
K833385 N-ACETYLPROCAINAMIDE CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. DLG Class I 1983-12-16
K832531 PHOTOMETER LP 300 Dr. Bruno Lange GmbH JJQ Class I 1983-12-12
K833312 ARTERIAL MICRO COLLECTION KIT Current Technologies, Inc. JKA Class II 1983-12-08
K832886 FLAME PHOTOMETER T281-T282-T283 Texas Intl. Laboratories, Inc. JJO Class I 1983-12-08
K833067 IMPACT 400 #1447X2 Gilford JJE Class I 1983-12-08
K833157 LANCER ANALYZER CUPS Sherwood Medical Co. JJC Class I 1983-12-08
K833154 NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM Nova Biomedical Corp. JJF Class I 1983-12-08
K832717 DIAGNON B12 57CO RIA KIT Diagnon Corp. CDD Class II 1983-12-08
K832801 OREIA II B-HCG, ENZYME INNUNOASSAY Organon, Inc. JHI Class II 1983-12-08
K833475 CAPIJECT SYS CAPILLARY BLOOD COLLECT Terumo Medical Corp. JKA Class II 1983-12-08
K833192 NORMAL URINE CONTROL Biosan Laboratories, Inc. JJY Class I 1983-12-08
K833257 WAKO GLUCOSE C Wako Chemicals USA, Inc. CGA Class II 1983-12-08
K833423 VENTREZYME EIA CONTROLS-IMMUNOASSAY Ventrex Laboratories, Inc. JJY Class I 1983-12-08
K833191 ABNORMAL URINE CONTROL Biosan Laboratories, Inc. JJY Class I 1983-12-08
K833320 AMBERLITE CG50 RESIN, 100-200 MESH Biosan Laboratories, Inc. KEA Class I 1983-12-08
K832783 MICRO-SAMPLE OSMOMETER 3M0 Advanced Instruments, Inc. JJM Class I 1983-11-28
K833146 AQUEOUS BLOOD GAS CONTROL Bionostics, Inc. JJS Class I 1983-11-28
K832889 AMYLASE Pointe Scientific, Inc., JFJ Class II 1983-11-25
K833153 NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU Nova Biomedical Corp. JJF Class I 1983-11-25
K833156 QUIDEL HCG ENZYME IMMUNOASSAY KIT Quidel Corp. JHJ Class II 1983-11-25
K833082 REAGENT SET TRIGLYCERIDES GPO Boehringer Mannheim Corp. CDT Class I 1983-11-25
K833159 POTASSIUM ELECTRODE TIP ASSAMBLY-K- Hi Chem, Inc. CEM Class II 1983-11-25
K833466 EARLY PREGNANCY DETECTION TEST KIT Quidel Corp. LCX Class II 1983-11-25
K832746 DUPONT LINEARIZATION MODULE E.I. Dupont DE Nemours & Co., Inc. JQP Class I 1983-11-25
K833113 REPORTING INTEGRATOR 3392A Hewlett-Packard Co. LDM Class I 1983-11-21
K833129 TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 Tago, Inc. MSJ Class I 1983-11-21
K832691 BETA SCAN REAGENT STRIP Orange Medical Instruments, Inc. CGA Class II 1983-11-14
K833005 PARAMAX BILIRUBIN CALIBRATORS American Dade JIX Class II 1983-11-14
K833072 TECHNICON RA-1000 SYS-ISE MODULE & Technicon Instruments Corp. JGS Class II 1983-11-14
K832942 TOTAL & DIRECT BILIRUBIN PROCEDURES Sandare Chemical Co., Inc. CIG Class II 1983-11-07
K833069 TDX GLUCOSE Abbott Laboratories CGA Class II 1983-11-07
K833116 SPIRIT CHEMISTRY SYSTEM Baker Instructions Corp. JJE Class I 1983-11-07
K833036 FLOW-PAC SODIUM REAGENT SET American Research Products Co. JGS Class II 1983-11-07
K831391 SHOT GUN KIT FOR CK-MB Serapine Corp. JHT Class II 1983-11-04
K833023 TECHNICON RA-1000 SYSTEM Technicon Instruments Corp. JJC Class I 1983-11-03
K832918 PREGNA-TEC Medilab Corp. JHJ Class II 1983-11-03
K832744 STARLYTE Electro-Nucleonics Laboratories, Inc. JGS Class II 1983-11-03
K833017 SERUM IRON & TIBC#65084 & 65085 Emd Chemicals, Inc. JIY Class I 1983-11-03
K833035 CALCIUM DYE REAGENT-CS-718-A/BUFFER Fisher Scientific Co., LLC CIC Class II 1983-11-03
K833319 BIO-REX 70 RESIN 100-200 MESH PH6.2 Biosan Laboratories, Inc. KEA Class I 1983-11-03
K831194 GLUCOKEY Ulster Scientific, Inc. CGA Class II 1983-10-31
K832813 TANDEM-E THYROID STIMULATING HORMONE KIT Hybritech, Inc. JLW Class II 1983-10-31
K832962 GAS CHROMATOGRAPH 5890A Hewlett-Packard Co. KZQ Class I 1983-10-28
K832941 BUN LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. CDQ Class II 1983-10-28
K832981 ELECTRODES FOR BLOOD GAS ANALYZERS Analytical Products, Inc. CHL Class II 1983-10-28
K832879 B-SLIDE PREGNATE PREGNANCY TEST KIT Fisher Scientific Co., LLC JHJ Class II 1983-10-28
K832926 ENZYMATIC GLUCOSE DETERMINATION Seragen Diagnostics, Inc. CGA Class II 1983-10-28
K833166 PROCEDURE 460 FOR DETERM. OF CHLORIDE Sigma Chemical Co. CHJ Class II 1983-10-28

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