meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
54
Latest Decision
1988-12-02

Clearances · page 76 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K884143 NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER Nova Biomedical Corp. CHL Class II 1988-12-02
K884085 TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY Hybritech, Inc. JHY Class II 1988-12-02
K883810 DELFIA TRIIODOTHYRONINE (T3) KIT Pharmacia, Inc. CDP Class II 1988-12-02
K884207 RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO Abbott Laboratories DHA Class II 1988-12-02
K884566 VISION LYTE (TM) POTASSIUM Abbott Laboratories CEM Class II 1988-12-02
K883745 IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES Diagnostic Products Corp. CGJ Class I 1988-11-30
K883826 HOME CLINIC PREGNANCY TEST Vanguard Biomedical Corp. LCX Class II 1988-11-29
K884433 TECHNICON ASSIST(R) CALCIUM METHOD Technicon Instruments Corp. CIC Class II 1988-11-29
K884138 ABBOTT IMX LH Abbott Laboratories CEP Class I 1988-11-29
K883585 TECHNICON ASSIST POTASSIUM Technicon Instruments Corp. CEJ Class II 1988-11-29
K884168 ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. The DU Pont Co. JIS Class II 1988-11-29
K884480 BIOTROL BILIRUBIN MONOREACTIF Biotrol, USA, Inc. CIC Class II 1988-11-29
K883586 TECHNICON RA-100 SYSTEM POTASSIUM Technicon Instruments Corp. CEJ Class II 1988-11-29
K883962 ROCHE REAGENT FOR INORGANIC PHOSPHORUS Roche Diagnostic Systems, Inc. CEO Class I 1988-11-29
K884105 AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) Amersham Corp. CHP Class I 1988-11-16
K881056 AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 American Research Products Co. JJC Class I 1988-11-15
K883972 MAGNESIUM REAGENT (MAGON SULFONATE) Sigma Chemical Co. JGJ Class I 1988-11-10
K884021 EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95 Em Diagnostic Systems, Inc. CFR Class II 1988-11-10
K884100 AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 Amersham Corp. JLS Class I 1988-11-10
K884548 LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 Em Diagnostic Systems, Inc. CFJ Class II 1988-11-10
K883942 HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL Icl Scientific JJY Class I 1988-11-10
K883749 PROBE(TM) MODELS 700 AND 1000 Packard Instrument Co., Inc. JQW Class I 1988-11-10
K883813 CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE Ciba Corning Diagnostics Corp. JKA Class II 1988-11-10
K884549 ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 Em Diagnostic Systems, Inc. CJE Class II 1988-11-10
K882192 HYGEIA URINE PREGNANCY TEST Hygeia Sciences DHA Class II 1988-11-10
K881168 CREATINE KINASE (CK) ISOENZYME MB Data Medical Associates, Inc. JHT Class II 1988-11-10
K880723 DIMENSION WHOLE BLOOD CHOLESTEROL Technimed, Inc. CHH Class I 1988-11-08
K883722 CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY Ciba Corning Diagnostics Corp. CDD Class II 1988-11-04
K883747 IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES Diagnostic Products Corp. CFT Class I 1988-11-01
K883878 AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) Amersham Corp. CFT Class I 1988-11-01
K880868 CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18 Diagnostic Chemicals, Ltd. (Usa) KHS Class II 1988-11-01
K882896 ONE-STEP HCG Wampole Laboratories DHA Class II 1988-10-31
K883267 IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) Diagnostic Products Corp. CDZ Class I 1988-10-31
K883765 TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE Biotecx Laboratories, Inc. KHQ Class II 1988-10-31
K883844 HI CHEM KINETIC CHOLESTEROL REAGENT #88218 Hichem Diagnostics CHH Class I 1988-10-31
K883646 BEHRING TURBITIMER Behring Diagnostics, Inc. JJQ Class I 1988-10-31
K883539 SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER Serono-Baker Diagnostics, Inc. JJE Class I 1988-10-31
K882059 BILIRUBIN STANDARD Verichem Laboratories, Inc. JIT Class II 1988-10-25
K883525 OXALATE REAGENT Sigma Chemical Co. LPW Class I 1988-10-25
K883104 CHEM 1 UIBC (IRON BINDING CAPACITY TEST) Technicon Instruments Corp. JMO Class I 1988-10-25
K883479 STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME Baxter Healthcare Corp CDP Class II 1988-10-25
K883971 QLIA T UPTAKE ASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic CEC Class II 1988-10-25
K882486 LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II Bio-Rad JJY Class I 1988-10-25
K883453 ROCHE REAGENT FOR CALCIUM Roche Diagnostic Systems, Inc. CJY Class II 1988-10-25
K882232 DISCOVER(R) Carter Products LCX Class II 1988-10-25
K883321 CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST Heraeus Kulzer, Inc. JJE Class I 1988-10-25
K883713 QM300 APOLIPOPROTEIN A-I ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. MSJ Class I 1988-10-19
K883714 QM300 APOLIPOPROTEIN B ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. MSJ Class I 1988-10-19
K883927 CIBA CORNING MAGIC LITE HCG IMMUNOASSAY Ciba Corning Diagnostics Corp. JHI Class II 1988-10-13
K883435 NOVASPEC II SPECTROPHOTOMETER Pharmacia, Inc. JJQ Class I 1988-10-13
K883387 ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) Tech-Co, Inc. CKD Class I 1988-10-13
K883946 VISION CREATINE KINASE Abbott Laboratories CGS Class II 1988-10-13
K883861 DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST Casco Standards JJY Class I 1988-10-13
K883326 TECHNICON RA(TM) SYSTEMS - MAGNESIUM Technicon Instruments Corp. JGJ Class I 1988-10-13
K882560 CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY Ciba Corning Diagnostics Corp. CEW Class II 1988-10-13
K883792 TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. JIY Class I 1988-10-12
K882895 MODIFIED BETA QUIK STAT EIA KIT Pacific Biotech, Inc. DHA Class II 1988-10-12
K882736 AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA Amersham Corp. JJY Class I 1988-10-11
K882588 BLUE DOT(TM) TEST FOR PREGNANCY V-Tech, Inc. LCX Class II 1988-10-06
K883777 CLEARVIEW HCG Unipath , Ltd. JHI Class II 1988-10-06
K883639 MODIFIED HCG IRMA KIT Pacific Biotech, Inc. JHI Class II 1988-10-06
K882728 AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190 Amersham Corp. JJY Class I 1988-10-06
K883147 TRACE ELEMENTS SERUM TOXICOLOGY CONTROL Utak Laboratories, Inc. JJY Class I 1988-10-06
K883386 CHLORIDE Tech-Co, Inc. CHJ Class II 1988-10-06
K883306 BINAS LUTEINIZING HORMONE IRMA TEST KIT Binax, Inc. JIT Class II 1988-10-06
K883305 BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY Binax, Inc. CGJ Class I 1988-10-06
K883741 QTEST PREGNANCY TEST CONTROL Quidel Corp. JJX Class I 1988-10-03
K881627 DELFIA(TM) NEONATAL HTSH KIT Pharmacia, Inc. JLW Class II 1988-10-03
K883222 ISOFOR-MM (TM) Intl. Immunoassay Laboratories, Inc. JHW Class II 1988-09-30
K883235 RAPIDTEST-HCG (TM) Synbiotics Corp. DHA Class II 1988-09-30
K883223 CHECK-MM Intl. Immunoassay Laboratories, Inc. JHS Class II 1988-09-30
K883124 AMERLITE FREE THYROID CONTROL SERA LAN.4002 Amersham Corp. JJY Class I 1988-09-30
K883320 MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE Sherwood Medical Co. JKA Class II 1988-09-27
K883316 QUIDEL PREGNANCY TEST CONTROL Quidel Corp. JJX Class I 1988-09-22
K883240 AVL MODEL 986 ELECTROLYTE ANALYZER Avl Scientific Corp. CEM Class II 1988-09-22
K882907 AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT Amersham Corp. JLW Class II 1988-09-22
K883395 ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY Quantimetrix Medical Industries JJT Class I 1988-09-19
K883181 SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE Beckman Instruments, Inc. CKA Class I 1988-09-19
K883503 COULTER VISCOMETER II Coulter Electronics, Inc. JJL Class I 1988-09-19
K883353 IQ HDL CHOLESTEROL Bd Becton Dickinson Vacutainer Systems Preanalytic LBR Class I 1988-09-13
K883209 TECHNICON RA-100(TM) SYSTEM Technicon Instruments Corp. JJE Class I 1988-09-13
K883302 EMAX PRECISION MICROPLATE READER Molecular Devices Corp. JJQ Class I 1988-09-13
K883269 PRL-QUANT Leeco Diagnostics, Inc. CFT Class I 1988-09-13
K883247 LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL Quantimetrix Medical Industries JJY Class I 1988-09-13
K883342 VENTREX COATED TUBE TSH Ventrex Laboratories, Inc. JLW Class II 1988-09-13
K883428 BIOTROL URIC ACID ENZYMATIQUE TRINDER Biotrol, USA, Inc. KNK Class I 1988-09-13
K883504 DURAZYME(R) CPK American Monitor Corp. CGS Class II 1988-09-13
K883404 URIC ACID REAGENT (PRODUCT #88219) Hichem Diagnostics KNK Class I 1988-09-13
K883405 TRIGLYCERIDES REAGENT (PRODUCT #88218) Hichem Diagnostics CDT Class I 1988-09-13
K882941 BLOOD GAS MIXTURE Swisco, Inc. CHL Class II 1988-09-09
K883085 T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS Serono Diagnostics, Inc. KHQ Class II 1988-09-09
K882938 STAT FAX(TM) Awareness Technology, Inc. JJQ Class I 1988-09-09
K882002 PREGNAGEN(TM) Biogenex Laboratories JHI Class II 1988-09-09
K883012 A.QC CHEMISTRY CONTROL LEVEL 2 Arden Medical Systems, Inc. JJY Class I 1988-09-09
K883279 PHASE II FSH KIT Vitek Systems, Inc. CGJ Class I 1988-09-09
K883206 LACTATE DEHYDROGENASE LDH Electro-Nucleonics, Inc. CFJ Class II 1988-09-09
K883205 ALTLTS ALANINE AMINO TRANSFERASE ALT Electro-Nucleonics, Inc. CKA Class I 1988-09-09
K882451 OLYMPUS REPLY CHEMISTRY ANALYZER Olympus Corp. JJE Class I 1988-09-08
K883491 TECHNICON DPA-1 APOLIPOPROTEIN B Technicon Instruments Corp. MSJ Class I 1988-09-07
K880973 MICROLYTE 7 The Rupp & Bowman Co. JFP Class II 1988-09-07

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