meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
54
Latest Decision
1988-09-02

Clearances · page 77 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K875285 MULTI-CHEMISTRY LINEARITY STANDARD Verichem Laboratories, Inc. JIX Class II 1988-09-02
K883020 RFA-300 RAPID FLOW ANALYZER W/COMPUTER Alpkem Corp. JJF Class I 1988-09-02
K883055 DART CARBON DIOXIDE Coulter Electronics, Inc. KHS Class II 1988-08-30
K882823 FIAGEN HGH FLUOROIMMUNOASSAY KIT Cyberfluor, Inc. CFL Class I 1988-08-30
K882914 VISTA INSTRUMENT Abbott Laboratories JJE Class I 1988-08-30
K882741 ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES Nichols Institute Diagnostics CKG Class II 1988-08-30
K882258 DC-LIQUICAL CATALOGUE #SE-030 Diagnostic Chemicals, Ltd. (Usa) JIX Class II 1988-08-30
K882913 DTR ANALYZER Abbott Laboratories JJE Class I 1988-08-30
K883059 WAKO(TM) AUTOKIT AMYLASE Wako Chemicals USA, Inc. CJA Class II 1988-08-30
K882801 RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN. Hf Scientific, Inc. JGS Class II 1988-08-29
K881868 LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD Supelco, Inc. DPM Class I 1988-08-29
K882608 LAD MODEL 633 LUMINOMETER Los Alamos Diagnostics JJQ Class I 1988-08-29
K882795 DADE(R) CK-MB IMMUNOASSAY CONTROL Baxter Healthcare Corp JJT Class I 1988-08-29
K882726 RAICHEM(TM) BILIRUBIN STANDARD Reagents Applications, Inc. JIS Class II 1988-08-29
K881015 FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT Pacific Biotech, Inc. JHI Class II 1988-08-29
K875049 MD STRIPS BG Amatech International, Inc. CGA Class II 1988-08-23
K882766 EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 Em Diagnostic Systems, Inc. DLG Class I 1988-08-23
K882488 CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES Canyon Diagnostics, Inc. LBR Class I 1988-08-15
K882334 ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT Abbott Laboratories CFR Class II 1988-08-09
K882614 MONOJECT(R) SNAP-OVER SAFETY CAP Sherwood Medical Co. JKA Class II 1988-08-09
K882587 A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM A-Kem, Inc. CIX Class II 1988-08-08
K882559 PROFILE ONE OMNI Modular Diagnostic Systems, Inc. JJE Class I 1988-08-08
K882539 CLEANTECH SYSTEM Schiff & Co. JKA Class II 1988-08-08
K882155 COTUBE HCG IRMA TEST Bio-Rad JHI Class II 1988-08-08
K882727 AMERLITE TOTAL THYROID CONTROL SERA LAN.4001 Amersham Corp. JJY Class I 1988-08-08
K882368 REP HDL ELECTROPHORESIS METHOD Helena Laboratories LBT Class I 1988-08-08
K881361 SOLID PHASE EXTRACTION TUBES Supelco, Inc. DJY Class I 1988-08-08
K882340 LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA Serono Diagnostics, Inc. CEP Class I 1988-08-08
K883013 IMX CKMB Abbott Laboratories JHY Class II 1988-08-08
K882256 MAGNESIUM REAGENT SET Tech-Neal Scientific, Inc. JGJ Class I 1988-08-08
K882586 A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM A-Kem, Inc. CIC Class II 1988-08-08
K882194 GEMINII GAMMA COUNTER Laboratory Technologies, Inc. JJE Class I 1988-08-04
K882252 PHASE II LH KIT Vitek Systems, Inc. CEP Class I 1988-08-04
K880437 VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM Abbott Laboratories CIG Class II 1988-08-03
K882095 MODIFICATION OF BEHRING RAPIMAT II/T Behring Diagnostics, Inc. JJQ Class I 1988-08-02
K882307 D-CHEM Photec Diagnostics, Inc. JJE Class I 1988-08-02
K882220 CALIBRATION KIT King Diagnostics, Inc. JIW Class II 1988-08-02
K882209 MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES Linde Div. Union Carbide Corp. CHL Class II 1988-08-02
K881806 QLT ABSOLUTE URINE-HCG PREGNANCY TEST Quadra Logic Technologies, Inc. JHI Class II 1988-08-02
K882459 DIAZO, COLORIMETRIC BILIRUBIN Tech-Neal Scientific, Inc. CIG Class II 1988-08-02
K882497 ENZYMATIC CO2 REAGENT SET American Monitor Corp. KHS Class II 1988-08-02
K882086 QTEST(TM) PREGNANCY Quidel Corp. JHI Class II 1988-07-28
K882450 GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK. Diamond Sensor Systems JJE Class I 1988-07-28
K882416 CLEARBLUE EASY Unipath , Ltd. LCX Class II 1988-07-28
K880933 AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST Amersham Corp. CEP Class I 1988-07-28
K882542 LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II Bio-Rad JJY Class I 1988-07-21
K881142 AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST Amersham Corp. CGJ Class I 1988-07-21
K882259 DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 Diagnostic Chemicals, Ltd. (Usa) JIT Class II 1988-07-21
K881381 REAGENTS FOR TSH ASSAY Sclavo, Inc. JLW Class II 1988-07-21
K882501 ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100 Terumo Medical Corp. GIM Class II 1988-07-18
K881908 TRACER(TM) II BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp. CGA Class II 1988-07-12
K881742 BIOTROL ALKALINE PHOSPHATASE Biotrol, USA, Inc. CJE Class II 1988-07-08
K881852 REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 Helena Laboratories JJN Class I 1988-07-08
K881709 IMMUNOCARD(TM) HCG II TEST KIT Disease Detection International, Inc. JHI Class II 1988-07-08
K880703 QUANTAI BG(TM) REAGENT STRIP Quantai Biotronics, Inc. CGA Class II 1988-07-08
K881761 UNSATURATED IRON BINDING CAPACITY Data Medical Associates, Inc. JMO Class I 1988-07-08
K881188 BLOOD PH CAPILLARY TUBES, HEPARIN Helps Products, Inc. CHL Class II 1988-07-08
K881430 LIQUI-SERA SERUM ALCOHOL CONTROLS Biodiagnostic Intl JJX Class I 1988-07-08
K881639 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT) Eastman Kodak Company CEK Class II 1988-07-08
K881503 MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL Baxter Healthcare Corp JJY Class I 1988-07-08
K882620 APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. MSJ Class I 1988-07-08
K881437 CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS Hichem Diagnostics JJY Class I 1988-07-06
K881438 UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN Hichem Diagnostics JJY Class I 1988-07-06
K882104 ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT. Paramax Systems Div. Baxter Healthcare JGS Class II 1988-07-05
K882189 BIOTROL TOTAL PROTEIN H.P. Biotrol, USA, Inc. CEK Class II 1988-07-01
K882343 TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT Terumo Medical Corp. CHP Class I 1988-07-01
K882081 SPECIFIC CHEMISTRY ANALYZER The Rupp & Bowman Co. JJE Class I 1988-07-01
K880750 NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT Nova Biomedical Corp. JGS Class II 1988-07-01
K881113 CLP LIPOPROTEIN ELECTROPHORESIS CONTROL Creative Laboratory Products, Inc. JJY Class I 1988-07-01
K875229 DSL SOMATOMEDIN-C (DSL #5600) Diagnostic Systems Laboratories, Inc. CFL Class I 1988-07-01
K881458 ASTROSCAN 2100 MICROTITER PLATE READER Astroscan , Ltd. JJQ Class I 1988-06-29
K882499 JAYCO HYDROGEN MONITOR Enteron, Inc. NRH Class I 1988-06-28
K882116 TOTAL PROTEIN/ALBUMIN STANDARD Verichem Laboratories, Inc. JIX Class II 1988-06-24
K882173 DELFIA ESTRADIOL KIT Pharmacia, Inc. CHP Class I 1988-06-24
K882163 HELENA REP GEL PROCESSOR Helena Laboratories JJN Class I 1988-06-20
K881856 BIOTROL CREATININE H.P. REAGENT Biotrol, USA, Inc. CGX Class II 1988-06-16
K881797 EASY WASHER II MICROPLATE WASHER Slt Labinstruments, Inc. JJQ Class I 1988-06-15
K881938 BICARBONATE (CO2) REAGENT-2 VIAL Trace Scientific , Ltd. KHS Class II 1988-06-15
K881898 MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B Atlantic Antibodies MSJ Class I 1988-06-14
K881244 HDL CHOLESTEROL KIT Trace Scientific , Ltd. LBR Class I 1988-06-10
K880576 RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID) Reagents Applications, Inc. CJY Class II 1988-06-10
K881877 COBAS EIA(TM) PHOTOMETER Roche Diagnostic Systems, Inc. JJQ Class I 1988-06-10
K881773 DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET Casco Standards JJR Class I 1988-06-10
K881891 IQ HDL CHOLESTEROL Bd Becton Dickinson Vacutainer Systems Preanalytic LBS Class I 1988-06-10
K864159 SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD Chem-Elec, Inc. CHH Class I 1988-06-10
K881855 EMIT CONVENIENCE PACK: T-UPTAKE ASSAY Syva Co. KHQ Class II 1988-06-10
K881774 PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic CFT Class I 1988-06-08
K881801 IMPRES-MB Intl. Immunoassay Laboratories, Inc. JHW Class II 1988-06-08
K881355 AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT Amersham Corp. JHI Class II 1988-06-08
K881798 TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN Technicon Instruments Corp. CIG Class II 1988-06-07
K881677 BUN (KINETIC) Boehringer Mannheim Corp. CDQ Class II 1988-06-07
K881195 DYNATECH SPD 2000, NUMBER 002-910-0000 Dynatech Laboratories, Inc. JQW Class I 1988-06-07
K881173 ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) Tech-Co, Inc. CIQ Class II 1988-06-07
K880654 AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 American Research Products Co. JIW Class II 1988-06-07
K881693 TERUMO SENSIBEAD EIA PROGESTERONE KIT Terumo Medical Corp. JIS Class II 1988-06-07
K881172 BILIRUBIN (DIRECT) Tech-Co, Inc. CIG Class II 1988-06-07
K874892 VITALOGRAPH-EC60 HYDROGEN MONITOR Vitalograph , Ltd. NRH Class I 1988-06-02
K881436 SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS Hichem Diagnostics JJY Class I 1988-06-02
K881194 RIA-QUICK Quantitative Technologies, Inc. JQP Class I 1988-06-01
K881495 SYNCHRON CX(TM)5 CLINICAL ANALYZER Beckman Instruments, Inc. JJE Class I 1988-06-01

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