meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
58
Latest Decision
1995-05-15

Clearances · page 51 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K951749 BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3 Biocell Laboratories, Inc. JJY Class I 1995-05-15
K951748 COAT-A-COUNT LH IRMA Diagnostic Products Corp. CEP Class I 1995-05-15
K950128 TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 Emd Chemicals, Inc. CEK Class II 1995-05-15
K951548 ACE AMYLASE REAGENT Schiapparelli Biosystems, Inc. JFJ Class II 1995-05-15
K951818 HICHEM ALT REAGENT KIT Hi Chem, Inc. CKA Class I 1995-05-15
K951586 T-UPTAKE EIA TEST Diagnostic Reagents, Inc. KHQ Class II 1995-05-15
K950524 NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY Nichols Institute JKC Class I 1995-05-15
K951752 ACTIVE IGF-I ELISA Diagnostic Systems Laboratories, Inc. CFL Class I 1995-05-10
K951707 DSL ACTIVE IFGBP-3 ELISA Diagnostic Systems Laboratories, Inc. CFL Class I 1995-05-10
K944618 NEONATAL BLOOD COLLECTION AND SCREENING FORM General Business Forms, Inc. JKA Class II 1995-05-10
K946354 DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE Data Medical Associates, Inc. JMO Class I 1995-05-08
K950958 SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA) Beckman Instruments, Inc. JJE Class I 1995-05-08
K945946 OSTEOMARK(R) Ostex Intl., Inc. JMM Class I 1995-05-08
K945908 GLUCOSE (HK) REAGENT (PROCEDURE NO.16) Sigma Diagnostics, Inc. CFR Class II 1995-05-08
K951630 AURAFLEX PROGESTERONE 150TEST PACK Organon Teknika Corp. JLS Class I 1995-05-08
K945367 CIBA CORNING ACS CORTISOL IMMUNOASSAY Ciba Corning Diagnostics Corp. CGR Class II 1995-05-05
K950432 VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1995-05-05
K950921 CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY Nichols Institute Diagnostics JLW Class II 1995-05-02
K946192 HICHEM Y-GT REAGENT KIT Hichem Diagnostics JQB Class I 1995-05-02
K951435 AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL Aalto Scientific, Ltd. JJR Class I 1995-05-02
K950292 FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM Miles, Inc. CGN Class II 1995-05-02
K951638 AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK Organon Teknika Corp. JHY Class II 1995-05-02
K943978 WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS Waters Chromatography Division JJF Class I 1995-05-02
K951360 ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM Bayer Corp. CHP Class I 1995-05-02
K943279 ACCUMETER HDL CHOLESTEROL TEST Chemtrak, Inc. LBS Class I 1995-05-01
K943436 URINE REAGENT STRIPS-8 PARAMETERS Teco Diagnostics JJB Class I 1995-04-24
K942376 COBAS CORE FREE T3 EIA Roche Diagnostic Systems, Inc. CEC Class II 1995-04-21
K945271 ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM Bio-Chem Laboratory Systems, Inc. JJE Class I 1995-04-20
K950353 TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM Miles, Inc. JJE Class I 1995-04-20
K951293 QUANTITATE ENZYME VERIFIER SET Beckman Instruments, Inc. JJT Class I 1995-04-20
K951136 BIONIKE A/Q PREGNANCY TEST Charlton Assoc. JHI Class II 1995-04-20
K951170 VIGIL MULTICHEK CONTROLS Beckman Instruments, Inc. JJY Class I 1995-04-20
K940486 DIGENE DCR-1 LUMINOMETER Digene Diagnostics, Inc. JJQ Class I 1995-04-18
K945454 LEUR TIP CAP, VLT CAP(TM) Martell Medical Products, Inc. JKA Class II 1995-04-14
K950211 ELSA-PTH Cis-Us, Inc. CEW Class II 1995-04-13
K950164 PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR Abaxis, Inc. CHH Class I 1995-04-13
K950469 DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET Casco Standards JJY Class I 1995-04-11
K950570 STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. JLS Class I 1995-04-11
K943965 VIVAPORE 10 Vivascience, Inc. JJH Class I 1995-04-11
K943966 VIVAPORE 2 Vivascience, Inc. JJH Class I 1995-04-11
K935319 CHEMILUMINESCENCE LH Nichols Institute Diagnostics CEP Class I 1995-04-05
K950510 OCTEIA IGF-1 KIT Immunodiagnostic Systems , Ltd. CFL Class I 1995-04-05
K945915 AVL OMNI ANALYZER Avl Scientific Corp. JJC Class I 1995-04-05
K945913 IRISPEC URINE CHEMISTRY CONTROL PART A AND B International Remote Imaging Systems JJW Class I 1995-04-05
K942361 WHITSOFT Biowhittaker Molecular Applications, Inc. JJQ Class I 1995-04-04
K942250 BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER Biowhittaker Molecular Applications, Inc. JJQ Class I 1995-04-04
K950072 IMMULITE(R) TBG Diagnostic Products Corp. JJX Class I 1995-04-03
K942245 BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE Biowhittaker Molecular Applications, Inc. JJQ Class I 1995-04-03
K946199 AURAFLEX(R) ESTRADIOL Organon Teknika Corp. CHP Class I 1995-04-03
K934178 ACCUSCREEN 17-HYDROXYPROGESTERONE Neometrics, Inc. JLX Class I 1995-03-30
K950590 REP CHOLESTEROL PROFILE CONTROL Helena Laboratories JJX Class I 1995-03-30
K950902 ALKO TONOMETERED SALINE CONTROL Alko Diagnostic Corp. JJS Class I 1995-03-30
K946387 CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER Capintec, Inc. JJJ Class I 1995-03-30
K950801 CARDIO REP LD CONTROL - CAT NO. 3325 Helena Laboratories JJT Class I 1995-03-30
K942648 IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET Teco Diagnostics JIL Class II 1995-03-24
K944768 OLYMPUS INORGANIC PHOSPHORUS REAGENT Olympus America, Inc. CEO Class I 1995-03-24
K942455 LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. CGA Class II 1995-03-24
K944728 BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL Bioresource Technology, Inc. JJY Class I 1995-03-23
K945887 PRECISION Q I D BLOOD GLUCOSE TEST STRIPS Medisense, Inc. CGA Class II 1995-03-23
K944195 QUICKPRO BLOOD GLUCOSE TESTING SYSTEM Medisense, Inc. CGA Class II 1995-03-23
K943767 IMMULITE C-PEPTIDE Diagnostic Products Corp. JKD Class I 1995-03-23
K943691 IMX FOLATE Abbott Mfg., Inc. CGN Class II 1995-03-23
K944525 LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3 Medical Analysis Systems, Inc. JJY Class I 1995-03-21
K946116 URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD Chemtech Labs, Inc. JIL Class II 1995-03-21
K943599 CHEM TRAK ACCUMETER Chemtrak, Inc. CHH Class I 1995-03-21
K950104 ELX800 AND EL800 AUTOMATED MICROPLATE READERS Bio-Tek Instruments, Inc. JJQ Class I 1995-03-21
K944698 AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 Organon Teknika Corp. CFT Class I 1995-03-21
K950589 CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL Creative Laboratory Products, Inc. JJX Class I 1995-03-20
K945331 AURAFLEX HCG Organon Teknika Corp. DHA Class II 1995-03-20
K950326 KENLOR HUMAN SPINAL FLUID CONTROL Kenlor Industries, Inc. JJY Class I 1995-03-20
K942735 CARBON DIOXIDE (C02) Teco Diagnostics KHS Class II 1995-03-20
K944406 OLYMPUS GLUCOSE REAGENT Olympus America, Inc. CFR Class II 1995-03-15
K943150 DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT Genzyme Corp. MRR Class I 1995-03-15
K950186 CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM Miles, Inc. JHW Class II 1995-03-13
K942782 PICCOLO(TM) Abaxis, Inc. JJG Class I 1995-03-13
K941427 SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) Teco Diagnostics JMK Class I 1995-03-13
K943195 COAT-A-COUNT NEONATAL TSH IRMA Diagnostic Products Corp. JLW Class II 1995-03-13
K942458 PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED Randox Laboratories, Ltd. JJY Class I 1995-03-13
K943882 ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM Radiometer America, Inc. CHL Class II 1995-03-10
K943416 DELFIA NEONATAL THYROXINE KIT Wallac OY CDX Class II 1995-03-10
K944933 IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) Diagnostic Products Corp. JMF Class II 1995-03-10
K936203 STAT PROFILE PLUS 10 ANALYZER Nova Biomedical Corp. CHL Class II 1995-03-09
K936066 STAT PROFILE PLUS 9 ANALYZER Nova Biomedical Corp. KHP Class I 1995-03-09
K945135 MICROPLATE PROCESSOR 3000 Organon Teknika Corp. JJE Class I 1995-03-03
K950177 CK QVET Prisma Systems CGS Class II 1995-03-03
K950307 BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST Princeton BioMeditech Corp. DHA Class II 1995-03-01
K942984 BUN REAGENT American Research Products Co. CDQ Class II 1995-03-01
K946355 DMA ALBUMIN PROCEDURE Data Medical Associates, Inc. CIX Class II 1995-03-01
K942658 NEOSCREEN ELISA TSH Pantex, Div. Bio-Analysis, Inc. JLW Class II 1995-02-24
K943193 COAT-A-COUNT(R) ESTRADIOL-6 Diagnostic Products Corp. CHP Class I 1995-02-23
K946022 HICHEM LDH/L REAGENT KIT Hichem Diagnostics CFJ Class II 1995-02-23
K946064 TOTAL CHOLESTEROL CASSETTE Cholestech Corp. CHH Class I 1995-02-22
K946063 TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL Cholestech Corp. CHH Class I 1995-02-22
K946163 RADIAS TOTAL T4 ENZYME IMMUNOASSAY Bio-Rad KLI Class II 1995-02-22
K950228 DSL ACTIVE IGFBP-3 IRMA (DSL 6600) Diagnostic Systems Laboratories, Inc. CFL Class I 1995-02-22
K944325 LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN Princeton BioMeditech Corp. JHW Class II 1995-02-22
K946067 TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL Cholestech Corp. CHH Class I 1995-02-22
K944697 AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK Organon Teknika Corp. CEC Class II 1995-02-22
K946183 CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER Heraeus Kulzer, Inc. KQO Class I 1995-02-22
K946065 TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL Cholestech Corp. CHH Class I 1995-02-22

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