meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
57
Latest Decision
1994-08-18

Clearances · page 54 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K942241 DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN Dupont Medical Products JKA Class II 1994-08-18
K942240 DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN Dupont Medical Products JKA Class II 1994-08-17
K940224 CARDIO REP LD Helena Laboratories CFE Class II 1994-08-17
K942566 IMX ULTRASENSISTIVE HTSH II Abbott Laboratories JLW Class II 1994-08-16
K941235 VISTA B12 ASSAY Syva Co. CDD Class II 1994-08-15
K941219 DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR Dupont Medical Products JIX Class II 1994-08-09
K943008 BIOSCAN REAGENT STRIPS Genesis Labs, Inc. JJB Class I 1994-08-08
K932556 AMMONIA ASSAY CAT. NO. 200-02 Diagnostic Chemicals, Ltd. (Usa) JIF Class I 1994-08-02
K940905 MICROTAINER BRAND TUBE WITH EDTA(K2) Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1994-08-02
K940271 INCSTAR ACTH IRMA Incstar Corp. CKG Class II 1994-08-02
K941433 HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH Hichem Diagnostics JJX Class I 1994-08-02
K943024 KINASE ISOENZYME Dupont Medical Products JHS Class II 1994-08-02
K935228 MODEL 644 SWEAT DILUENT Ciba Corning Diagnostics Corp. CGZ Class II 1994-08-01
K940735 LIQUID AMYLASE (CNPG3) REAGENT SET Pointe Scientific, Inc., CIJ Class II 1994-08-01
K942549 ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS Alko Diagnostic Corp. JIX Class II 1994-07-28
K940507 OPUS FT4 TEST SYSTEM Pb Diagnostic Systems, Inc. CEC Class II 1994-07-28
K942616 AVL COMPACT 2 PH/BLOOD GAS ANALYZER Avl Scientific Corp. CHL Class II 1994-07-28
K941698 SERUM VOLATILES CONTROL - LEVELS 1 AND 2 More Diagnostics JJY Class I 1994-07-28
K941876 WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 More Diagnostics JJY Class I 1994-07-28
K942575 CEDIA T4 MAB ASSAY Microgenics Corp. KLI Class II 1994-07-28
K941115 ACS CARDIO-TROL CONTROL Analytical Control Systems, Inc. JJY Class I 1994-07-20
K935984 GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 Sigma Diagnostics, Inc. JQB Class I 1994-07-20
K941063 DNA TRIGLYCERIDE PROCEDURE Data Medical Associates, Inc. JGY Class I 1994-07-20
K941221 DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE Dupont Medical Products CGJ Class I 1994-07-20
K941314 STANBIO ALT/GPT (LUQUI-UV) TEST SET Stanbio Laboratory CKA Class I 1994-07-20
K940289 ABBOTT PRISM ANALYZER Abbott Mfg., Inc. JJE Class I 1994-07-18
K941315 STANBIO Y-GT (LIQUICOLOR) TEST SET Stanbio Laboratory JQB Class I 1994-07-14
K941498 BIOMEK SL WITH BIOMEK SL INCUBATOR Beckman Analytical and Biotechnology Development JQW Class I 1994-07-14
K936229 AIA-PACK TT3 ASSAY Tosoh Medics, Inc. CDP Class II 1994-07-14
K942051 SR1 DHEA-S ENZYME IMMUNOASSAY Serono Diagnostics, Inc. JKC Class I 1994-07-13
K941355 PREGNANCY CHECK Sa Scientific, Inc. LCX Class II 1994-07-06
K934293 BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT Beckman-Diagnostic Systems Group JFJ Class II 1994-07-06
K930047 DSL IGFBP-3 RIA (DSL 6700) Diagnostic Systems Laboratories, Inc. CFL Class I 1994-07-06
K941771 BODYWISE PREGNANCEY TEST Charlton Assoc. LCX Class II 1994-07-06
K941584 CREATINE KINASE METHOD Dupont Medical Products JHS Class II 1994-07-06
K935924 AXSYM CK-MB Abbott Laboratories JHW Class II 1994-06-21
K935611 AXSYM LUTEINIZING HORMONE (LH) Abbott Laboratories JJX Class I 1994-06-21
K934312 AXSYM(TM) T-UPTAKE Abbott Laboratories KHQ Class II 1994-06-21
K934410 AXSYM ULTRASENSITIVE HTSH Abbott Laboratories JLW Class II 1994-06-21
K935612 AXSYM FOLLICLE STIMULATING HORMONE (FSH) Abbott Laboratories CGJ Class I 1994-06-21
K935673 AXSYM TOTAL B-HCG Abbott Laboratories JHI Class II 1994-06-21
K934517 AXSYM TOTAL T3 Abbott Laboratories CDP Class II 1994-06-21
K935675 AXSYM PROLACTIN Abbott Laboratories CFT Class I 1994-06-21
K934544 AXSYM FREE THYROXINE ( FREE T4 ) Abbott Laboratories CEC Class II 1994-06-21
K934384 AXSYM(TM) TOTAL T4 Abbott Laboratories CDX Class II 1994-06-21
K935013 DSL ESTRONE (DSL 8700) Diagnostic Systems Laboratories, Inc. CGF Class I 1994-06-16
K941912 N/T PROTEIN CONTROL SY/L, M, AND H Behring Diagnostics, Inc. JJY Class I 1994-06-16
K935408 UA PERFECT Chimera Research & Chemical, Inc. KQO Class I 1994-06-13
K940577 GLUCOMETER ELITE LOW CONTROL Heraeus Kulzer, Inc. JJX Class I 1994-06-13
K941220 DUPONT ACA PLUS PROLACTIN (PROL) METHOD Dupont Medical Products CFT Class I 1994-06-03
K941394 STAT FAX 2600 Awareness Technology, Inc. JQW Class I 1994-06-03
K941130 ASSURE URINE HCG CONTROL Quantimetrix Corp. JJX Class I 1994-06-03
K940457 LIPASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. CET Class I 1994-06-02
K940637 PREDICTOR HOME PREGNANCY TEST Organon Teknika Corp. LCX Class II 1994-06-02
K932606 APOLIPOPROTIEN A-1 (APO A-1) Sigma Diagnostics, Inc. JHN Class I 1994-06-02
K941090 UNISTEP HCG PREGNANCY TEST STRIP Biotech Atlantic, Inc. DHA Class II 1994-06-02
K932603 APOLIPOPROTIEN B (APO B) Sigma Diagnostics, Inc. JHN Class I 1994-06-02
K941175 ACCESS PROLACTIN Bio-Rad Laboratories, Inc. CFT Class I 1994-06-02
K941326 ULTRAFREE-CL Millipore Corp. JJH Class I 1994-05-27
K935121 ABL SYSTEM 620 Radiometer America, Inc. CHL Class II 1994-05-27
K935655 ABL5 BLOOD GAS SYSTEM Radiometer America, Inc. CHL Class II 1994-05-27
K941497 SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY Solarcare, Inc. CKA Class I 1994-05-24
K940810 CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF Ciba Corning Diagnostics Corp. JJE Class I 1994-05-23
K935047 AUTO DELFIA Wallac OY KHO Class I 1994-05-23
K941159 DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G International Technidyne Corp. JKA Class II 1994-05-19
K933794 ANI BIOCARD(TM) HCG TEST Canadian Bioclinical, Ltd. LCX Class II 1994-05-19
K941313 STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET Stanbio Laboratory CJE Class II 1994-05-17
K941085 LIPASE-PS ASSAY PROCEDURE NO. 805 Sigma Diagnostics, Inc. CHI Class I 1994-05-17
K941764 HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 Hi Chem, Inc. CJY Class II 1994-05-13
K934317 CIDBA CORNING ACS CORTISOL IMMUNOASSAY Ciba Corning Diagnostics Corp. JFT Class II 1994-05-13
K940918 I-STAT 200 PORTABLE CLINICAL ANALYZER I-Stat Corp. CHL Class II 1994-05-10
K936212 GLUCOFILM TEST STRIPS Heraeus Kulzer, Inc. CGA Class II 1994-05-10
K940008 GLYCATED PROTEIN CALIBRATORS Primus Corp. JIS Class II 1994-05-09
K935014 ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) Diagnostic Systems Laboratories, Inc. JKC Class I 1994-05-09
K936202 URINARY ALBUMIN TEST PACK Dupont Medical Products JIQ Class I 1994-05-09
K941091 SYNERMED AMYLASE REAGENT KIT Synermed, Inc. JFJ Class II 1994-05-03
K941287 LIQUID ALT(SGPT) REAGENT SET Pointe Scientific, Inc., CKA Class I 1994-05-03
K940390 IMPACT Matrix Technologies Corp. JQW Class I 1994-05-03
K940058 MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER Sherwood Medical Co. GIM Class II 1994-05-02
K941132 LIQUID AST (SGOT)REAGENT SET Pointe Scientific, Inc., CIT Class II 1994-05-02
K935515 MULTICHECK(TM) Radiometer America, Inc. JJS Class I 1994-04-26
K934068 BECKMAN DIRECT BILIRUBIN REAGENT Beckman-Diagnostic Systems Group CIG Class II 1994-04-26
K934013 RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT Isolab, Inc. CIN Class II 1994-04-26
K936258 SYSTEM WASHER 100 Eg&G Berthold JQW Class I 1994-04-26
K935120 EML 100 Radiometer America, Inc. JGS Class II 1994-04-26
K940142 GLYCATED PROTEIN CONTROLS Primus Corp. JJX Class I 1994-04-26
K935496 NANOSEP N10 Intersep , Ltd. JJH Class I 1994-04-26
K935806 IMMULITE DHEA-S04 Diagnostic Products Corp. JKC Class I 1994-04-26
K941400 SYNERMED ISE REAGENTS Synermed, Inc. JGS Class II 1994-04-26
K940221 ACCESS CORTISOL REAGENTS Bio-Rad Laboratories, Inc. CGR Class II 1994-04-26
K935666 PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP The Perkin-Elmer Corp. KIE Class I 1994-04-26
K941042 CEDIA T4 MAB ASSAY Microgenics Corp. KLI Class II 1994-04-26
K935662 SYNERMED IR 500 CHEMISTRY ANALYZER Synermed, Inc. JIQ Class I 1994-04-26
K940482 CIBA CORNING ACS FT3 IMMUNOASSAY Ciba Corning Diagnostics Corp. CEC Class II 1994-04-26
K924392 CARDIAC T ELISA TROPONIN-T Boehringer Mannheim Corp. MMI Class II 1994-04-26
K941156 TECHNISON AXON SYSTEM Miles, Inc. KHS Class II 1994-04-26
K934925 BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR Beckman Instruments, Inc. JIF Class I 1994-04-26
K934413 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE Eastman Kodak Company CIT Class II 1994-04-25
K932728 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) Eastman Kodak Company KNK Class I 1994-04-25
K940571 SYNERMEDIR CAL I AND SYNERMED IR CAL II Synermed, Inc. JIX Class II 1994-04-21

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