meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
60
Latest Decision
1990-01-02

Clearances · page 71 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K896640 MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. CGJ Class I 1990-01-02
K896202 MATRIX(TM)-96 Canberra Industries, Inc. JJJ Class I 1990-01-02
K896692 AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER Baxter Healthcare Corp CEM Class II 1990-01-02
K896643 HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 Medix Biotech, Inc. CFL Class I 1989-12-29
K895883 BECKMAN MA MICROALBUMIN REAGENT KIT Beckman Instruments, Inc. JIQ Class I 1989-12-27
K896802 MAGNET PAD Westmark, Sterile Packing Systems, Inc. (Sps) LXG Class I 1989-12-27
K894423 ACC.U.DIAL Exocell, Inc. JJQ Class I 1989-12-27
K895943 NORMAL AND ABNORMAL CONTROL SERA Sclavo, Inc. JJY Class I 1989-12-27
K896145 ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. CHP Class I 1989-12-27
K896641 MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. CFT Class I 1989-12-27
K895139 CLINISTAT HDL CHOLESTEROL REAGENT TEST Heraeus Kulzer, Inc. LBS Class I 1989-12-27
K895555 MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) Hichem Diagnostics CJA Class II 1989-12-22
K895748 BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. KHS Class II 1989-12-21
K895880 PANCREATIC A-AMYLASE EPS Boehringer Mannheim Corp. CIL Class II 1989-12-19
K894175 SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY Serono-Baker Diagnostics, Inc. JHI Class II 1989-12-19
K896144 AUTOSCAN, AUTOSTRIP AND AUTOCONTROL Cascade Medical, Inc. CGA Class II 1989-12-19
K896007 COBAS READY Roche Diagnostic Systems, Inc. JJQ Class I 1989-12-19
K896073 CHOLESTEROL, UNIVERSAL ET Enzyme Technology, Inc. CHH Class I 1989-12-12
K895397 CALCIUM AND PH ELECTROLYTE ANALYZER Ionetics, Inc. JFP Class II 1989-12-12
K896451 MODIFIED CEDIA(TM) CORTISOL ASSAY Microgenics Corp. CGR Class II 1989-12-12
K896270 AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 Amersham Corp. CHP Class I 1989-12-12
K895873 CALCIUM, CATALOGUE NUMBER140-20 Diagnostic Chemicals, Ltd. (Usa) CJY Class II 1989-12-12
K895936 EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER Medica Corp. JGS Class II 1989-12-12
K896329 D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. Photec Diagnostics, Inc. KLI Class II 1989-12-12
K895421 CORTISOL TEST SYSTEM Baxter Healthcare Corp JFT Class II 1989-12-07
K895821 URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. KNK Class I 1989-12-05
K895850 SYNCHRON CX SYSTEMS (LAP) REAGENT KIT Beckman Instruments, Inc. JGG Class I 1989-12-05
K895809 MILENIA(TM) HCG (MKCG1,5) Diagnostic Products Corp. JHI Class II 1989-12-01
K895870 ISOSCREEN-CK CONFIRMATORY KIT Roche Diagnostic Systems, Inc. JHY Class II 1989-12-01
K895912 IMMUNOCARD HCG II-S TEST KIT Disease Detection International, Inc. JHI Class II 1989-12-01
K896117 MODIFIED MODEL 535(TM) LUMINOMETER Los Alamos Diagnostics JJQ Class I 1989-11-30
K895851 SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT Beckman Instruments, Inc. LBS Class I 1989-11-29
K896206 STATSPIN STATSAMPLER Statspin Technologies JKA Class II 1989-11-22
K896294 DSL I-PTH (DSL #8000) Diagnostic Systems Laboratories, Inc. CEW Class II 1989-11-21
K893038 PROTOFLUOR Z Helena Laboratories JKJ Class I 1989-11-17
K896222 FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT Nichols Institute Diagnostics CEC Class II 1989-11-17
K895664 TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD Technicon Instruments Corp. CEM Class II 1989-11-14
K895778 QUANTIMETRIX BILIRUBIN CALIBRATORS Quantimetrix Medical Industries JIS Class II 1989-11-14
K896028 GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 American Research Products Co. CFR Class II 1989-11-14
K895822 TOTAL BILIRUBIN L.F. Sclavo, Inc. CIG Class II 1989-11-14
K895560 MODIFIED HOMECLINIC PREGNANCY TEST Vanguard Biomedical Corp. LCX Class II 1989-11-13
K895585 HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) Hichem Diagnostics JIS Class II 1989-11-13
K895390 CARDS O.S. (TM) HCG-URINE Pacific Biotech, Inc. JHI Class II 1989-11-13
K896001 ALANINE AMINOTRANSFERASE (ALT) American Monitor Corp. CKA Class I 1989-11-13
K894715 CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. CGS Class II 1989-11-08
K895186 FIAGEN T3 UPTAKE CATALOGUE #101-402 Cyberfluor, Inc. KHQ Class II 1989-11-08
K895984 WAKO(TM) AUTOKIT GAMMA-GT Wako Chemicals USA, Inc. JPZ Class I 1989-11-08
K895911 ONE TOUCH II METER Lifescan, Inc. CGA Class II 1989-11-08
K895381 HDL SINGLES Trace America, Inc. LBR Class I 1989-11-08
K893661 QUANTAI UG REAGENT STRIP Quantai Biotronics, Inc. CGA Class II 1989-11-08
K894006 SANISERV SURGICAL SLUSH SYSTEM Saniserv, Inc. JRM Class I 1989-11-03
K894238 ABBOTT TDX TOTAL T3 PLUS Abbott Laboratories CDP Class II 1989-10-31
K895396 CYBERFLUOR FIAGEN TSH Cyberfluor, Inc. JLW Class II 1989-10-31
K895249 SYSTEMATE(TM) IRON ITEM NUMBER: 65417 Em Diagnostic Systems, Inc. JIY Class I 1989-10-31
K895250 SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 Em Diagnostic Systems, Inc. CJE Class II 1989-10-31
K895094 TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. CEP Class I 1989-10-31
K894035 EOS CHEMISTRY ANALYZER Eos Technology Corp. JGS Class II 1989-10-31
K894859 LP 400 MICROPLATE READER Kallestad Diag, A Div. of Erbamont, Inc. JJQ Class I 1989-10-31
K895288 HVA EIA KIT YAMASA Yamasa Shoy Co., Ltd. CDF Class I 1989-10-31
K893954 CEDIA CORTISOL ASSAY Microgenics Corp. JFT Class II 1989-10-31
K895005 MILENIA(TM) FSH (MKFS1,5) Diagnostic Products Corp. CGJ Class I 1989-10-31
K895723 IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) Diagnostic Products Corp. JFH Class II 1989-10-31
K893975 DOUBLE ANTIBODY GLUCAGON Diagnostic Products Corp. JME Class I 1989-10-31
K892329 OSMOMETER STANDARD SOLUTIONS D.R.G. Scientific Industries JIT Class II 1989-10-31
K894836 DART UREA NITROGEN Coulter Electronics, Inc. CDQ Class II 1989-10-30
K895847 CREATININE 340 (ENZYMATIC) Sclavo, Inc. CGX Class II 1989-10-30
K894576 CIBA CORNING CERTAIN LYTE Ciba Corning Diagnostics Corp. JJR Class I 1989-10-30
K895967 FASTEC 901 AGGLUTINATION PATTERN READER Schiff & Co. JJQ Class I 1989-10-30
K895287 VMA EIA KIT YAMASA Yamasa Shoy Co., Ltd. CDF Class I 1989-10-30
K895666 BUN (KINETIC) Boehringer Mannheim Corp. CDQ Class II 1989-10-27
K891070 PHENYLALANINE (NINHYDRIN REACTION) Alpkem Corp. JNB Class II 1989-10-27
K894966 PLASMA CATECHOLAMINES BY HPLC Bio-Rad CHQ Class I 1989-10-25
K894790 QUIDEL HCG TEST Quidel Corp. JHI Class II 1989-10-25
K894941 COAT-A-COUNT (TM) HCG IRMA Diagnostic Products Corp. JHI Class II 1989-10-25
K895528 GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 Helena Laboratories JJX Class I 1989-10-25
K895672 TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD Technicon Instruments Corp. JGS Class II 1989-10-25
K894400 MICRO-PLATE READER, MDX-1 Medix Biotech, Inc. JJX Class I 1989-10-23
K895135 HI CHEM CALIBRATOR A+ Hichem Diagnostics JIX Class II 1989-10-23
K895006 MILENIA(TM) CORTISOL (MKCO1,5) Diagnostic Products Corp. CGR Class II 1989-10-23
K895108 FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. Bd Becton Dickinson Vacutainer Systems Preanalytic CGJ Class I 1989-10-23
K895022 SYSTEMATE CREATININE TEST (CREA) #65413 Em Diagnostic Systems, Inc. CGX Class II 1989-10-23
K895665 URIC ACID PAP Boehringer Mannheim Corp. KNK Class I 1989-10-23
K895138 CLINISTAT LDH REAGENT TEST Heraeus Kulzer, Inc. CFH Class II 1989-10-19
K895407 CORTISOL CLASP-BEAD EIA KIT Biotecx Laboratories, Inc. CGR Class II 1989-10-19
K895840 MILENIA(TM) TOTAL T4 (MKT41,5) Diagnostic Products Corp. CDP Class II 1989-10-19
K895718 LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER Data Medical Associates, Inc. JGM Class II 1989-10-19
K894750 BIOSTIX I. HCG - ONE STEP PREGNANCY TEST Princeton Biomedix JHI Class II 1989-10-18
K894705 BIOSPOT HCG-RAPID PREGNANCY TEST Princeton Biomedix JHI Class II 1989-10-18
K895119 SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 Em Diagnostic Systems, Inc. CIG Class II 1989-10-17
K895313 MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER Dynatech Laboratories, Inc. JJQ Class I 1989-10-17
K895047 CLINISTAT POTASSIUM REAGENT TEST Heraeus Kulzer, Inc. CFM Class I 1989-10-17
K894578 IQ LDH Bd Becton Dickinson Vacutainer Systems Preanalytic CFH Class II 1989-10-17
K895380 SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. CFT Class I 1989-10-17
K895118 SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407 Em Diagnostic Systems, Inc. CIG Class II 1989-10-17
K894902 SOURCERER Oakfield Instruments, Ltd. JJJ Class I 1989-10-17
K894554 CLP CK/LD ISOENZYME CONTROL Creative Laboratory Products, Inc. JJT Class I 1989-10-16
K894914 MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK I-Stat Corp. JGS Class II 1989-10-16
K895526 COBAS READY GLUCOSE REAGENT Roche Diagnostic Systems, Inc. CGA Class II 1989-10-16
K894993 STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. Baxter Healthcare Corp CDP Class II 1989-10-13
K894988 CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY Ciba Corning Diagnostics Corp. CFT Class I 1989-10-12

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