meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
63
Latest Decision
1990-11-02

Clearances · page 67 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K904503 SERACON CR REFERENCE Bhp Diagnostix, Inc. JJX Class I 1990-11-02
K904163 CLINICAL BLOOD GAS MIXTURES Norco, Inc. LCH Class I 1990-11-01
K904141 TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III Medical Analysis Systems, Inc. JJY Class I 1990-11-01
K904405 BIOCLONES ELEGANCE FSH ELISA KIT Bioclone Australia Pty , Ltd. CGJ Class I 1990-10-26
K904099 URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS Hichem Diagnostics JJY Class I 1990-10-26
K903725 EZ-BEAD TSH ENZYME IMMUNOASSAY KIT Immunotech Corp. JLW Class II 1990-10-26
K904219 SYNCHRON CX 7 CLINICAL ANALYZER Beckman JJE Class I 1990-10-22
K903937 TARGET(TM) HOG ONE STEP V-Tech, Inc. JHI Class II 1990-10-22
K903609 SEROTONIN ENZYME IMMUNOASSAY Immunotech Corp. CDA Class I 1990-10-22
K904292 ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp. CGA Class II 1990-10-22
K904306 DUPONT DRUG CALIBRATOR-A E.I. Dupont DE Nemours & Co., Inc. JJX Class I 1990-10-15
K903191 QUICK CHECK 3 FILM Quantai Biotronics, Inc. CGA Class II 1990-10-15
K904016 MAXI TEST Bhc Biotech , Ltd. JHI Class II 1990-10-15
K903626 BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA Beckman Instruments, Inc. JJG Class I 1990-10-15
K904220 SYNCHRON CX4-CE Beckman JJE Class I 1990-10-15
K904100 DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300) Diagnostic Systems Laboratories, Inc. CDZ Class I 1990-10-15
K904168 ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp. CGA Class II 1990-10-15
K903433 TDX FREE T3 CALCULATION Abbott Laboratories CDP Class II 1990-10-12
K904458 LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION London Diagnostics, Inc. CFT Class I 1990-10-12
K903543 SYNERMED ALBUMIN REAGENT KIT Synermed, Inc. CIX Class II 1990-10-12
K903396 IL T UPTAKE ASSAY SYSTEM Instrumentation Laboratory CO KHQ Class II 1990-10-12
K903304 ROCHE COBAS READY GGT REAGENT Roche Diagnostic Systems, Inc. JPZ Class I 1990-10-12
K902786 MILENIA (TM) LH Diagnostic Products Corp. CEP Class I 1990-10-12
K903391 ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM Nichols Institute JLW Class II 1990-10-12
K904293 HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) Hichem Diagnostics JJY Class I 1990-10-12
K903773 SYNERMED LDH REAGENT KIT Synermed, Inc. CFJ Class II 1990-10-12
K904049 ROCHE COBAS READY RENAL PROFILE REAGENT STRIP Roche Diagnostic Systems, Inc. JGZ Class II 1990-10-12
K904335 SECONDARY CALIBRATORS Bionostics, Inc. JGS Class II 1990-10-12
K904381 DIAZO COLORIMENTRY DIRECT BILIRUBIN Amresco, Inc. CIG Class II 1990-10-12
K903933 DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2 Baxter Healthcare Corp JJY Class I 1990-10-04
K903233 SYNERMED CALCIUM REAGENT KIT Synermed, Inc. CIC Class II 1990-10-04
K902575 SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) Diagnostic Products Corp. JIW Class II 1990-10-04
K903409 SYSTEMATE BICARBONATE OLYMPUS BICARBONATE Em Diagnostic Systems, Inc. KHS Class II 1990-10-04
K903911 GEN-PROBE PAL LUMINOMETER Gen-Probe, Inc. JJQ Class I 1990-10-04
K903775 CREATINE PHOSPHOKINASE Amresco, Inc. CGS Class II 1990-10-04
K902442 SUDORMED SWEAT PATCH SPECIMEN CONTAINER Sudormed, Inc. JKA Class II 1990-10-04
K904123 CIBA CORNING ACS HCG IMMUNOASSAY Ciba Corning Diagnostics Corp. JHI Class II 1990-10-03
K903914 PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK Baxter Healthcare Corp JGQ Class II 1990-10-03
K903897 TRIGLYCERIDES REAGENT GPO 5 X CONC. Trace Scientific , Ltd. CDT Class I 1990-10-01
K893582 N-A-G TEST KIT Ppr Diagnostics , Ltd. CGX Class II 1990-10-01
K903015 SYNERMED CHOLESTEROL REAGENT KIT Synermed, Inc. CHH Class I 1990-10-01
K903357 SYVA(R) ETS(R) PLUS SYSTEM Syva Co. JJF Class I 1990-09-27
K904102 REFLOTRON CREATINE KINASE TEST TABS Boehringer Mannheim Corp. CGS Class II 1990-09-27
K903071 KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN Eastman Kodak Company JJE Class I 1990-09-27
K903305 TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD Technicon Instruments Corp. KHS Class II 1990-09-27
K903231 COULOCHEM II Esa, Inc. LEQ Class I 1990-09-27
K904116 IRON 5 X CONC REAGENT Trace Scientific , Ltd. JMO Class I 1990-09-27
K903913 PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II Baxter Healthcare Corp JIX Class II 1990-09-27
K903727 SYNERMED URIC ACID REAGENT KIT Synermed, Inc. KNK Class I 1990-09-27
K904098 CEDIA TOTAL T3 ASSAY Microgenics Corp. CDP Class II 1990-09-27
K903888 HI CHEM PROTEIN/LIPIDS LINEARITY Hichem Diagnostics JIX Class II 1990-09-27
K902935 ROCHE COBAS READY HDL CHOLESTEROL REAGENT Roche Diagnostic Systems, Inc. JHM Class I 1990-09-27
K904030 SYNERMED ALKALINE PHOSPHATASE REAGENT KIT Synermed, Inc. CJE Class II 1990-09-27
K904188 CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER Ciba Corning Diagnostics Corp. CHL Class II 1990-09-27
K903934 GEN-PROBE LUMINOMETER-LEADER 50 Gen-Probe, Inc. JJQ Class I 1990-09-27
K902678 LIQUID STABLE CHOLESTEROL REAGENT KIT Trace Scientific , Ltd. CHH Class I 1990-09-25
K903219 ABBOTT TESTPACK PLUS TM HCG-COMBO Abbott Laboratories JHI Class II 1990-09-25
K903144 KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2) Eastman Kodak Company KHS Class II 1990-09-25
K903829 AST REAGENT Amresco, Inc. CIT Class II 1990-09-25
K903130 LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY London Diagnostics, Inc. CEW Class II 1990-09-25
K903566 DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III Baxter Healthcare Corp JJY Class I 1990-09-24
K903728 SYNERMED DIRECT BILIRUBIN REAGENT KIT Synermed, Inc. CIG Class II 1990-09-21
K900856 VEN-O-VAC BLOOD COLLECTION VACUUM TUBES Artefactos DE Vidrio S.A. DE C.V. JKA Class II 1990-09-21
K902937 MILENIA PAP IRMA CATALOG #: MKPA1, X Diagnostic Products Corp. JFH Class II 1990-09-21
K903123 RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT Reagents Applications, Inc. JIQ Class I 1990-09-14
K903063 SYNERMED GLUCOSE REAGENT KIT Synermed, Inc. CGA Class II 1990-09-13
K904007 BICARBONATE REAGENTS AMRESCO PRODUCT #4326020 Amresco, Inc. KHS Class II 1990-09-13
K903896 CALCIUM ARSENAZO III REAGENT Trace Scientific , Ltd. CIC Class II 1990-09-13
K903696 OLYMPUS INORGANIC PHOSPHORUS Em Diagnostic Systems, Inc. CEO Class I 1990-09-12
K903198 ALANINE AMINOTRANSFERASE TEST Em Diagnostic Systems, Inc. CKA Class I 1990-09-12
K903647 MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE Millipore Corp. LDM Class I 1990-09-11
K903383 TDX FREE T4 CALCULATION Abbott Laboratories CEC Class II 1990-09-10
K903384 IMX FREE T4 CALCULATION Abbott Laboratories CEC Class II 1990-09-10
K903616 DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) Diagnostic Systems Laboratories, Inc. JKC Class I 1990-09-10
K903188 ABBOTT VISION LYTE (TM) SODIUM Abbott Laboratories JGS Class II 1990-09-10
K903628 AIA-PACK IRI Tosoh Corp. CFP Class I 1990-09-07
K903311 NOVAPATH TSH ENZYME IMMUNOASSAY Bio-Rad JLW Class II 1990-09-07
K902561 ROCHE COBAS READY CREATININE REAGENT Roche Diagnostic Systems, Inc. CGX Class II 1990-09-07
K902834 ABBOTT IMX FREE T4 Abbott Laboratories CEC Class II 1990-09-07
K903432 IMX FREE T3 CALCULATION Abbott Laboratories CDP Class II 1990-09-07
K903407 AFFINITY HLH TEST SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic JJY Class I 1990-09-07
K902543 ACID PHOSPHOTASE REAGENT TEST AND KIT Crestat Diagnostics, Inc. CKB Class II 1990-09-07
K903309 ROCHE COBAS READY AMYLASE REAGENT Roche Diagnostic Systems, Inc. JFJ Class II 1990-09-07
K903573 REFLOTRON CREATININE TEST TABS Boehringer Mannheim Corp. JFY Class II 1990-09-07
K903334 UREA NITROGEN TEST Em Diagnostic Systems, Inc. CDQ Class II 1990-09-07
K903508 LABELLING CHANGES TO IMPRES-MB-X Intl. Immunoassay Laboratories, Inc. JHW Class II 1990-09-07
K903310 CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR Medical Analysis Systems, Inc. JJY Class I 1990-09-07
K903338 KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL Kenlor Industries, Inc. JJY Class I 1990-09-07
K903511 SYNERMED TOTAL PROTEIN REAGENT KIT Synermed, Inc. CEK Class II 1990-09-07
K903052 IMMUNOCORP LH IRMA COATED TUBE Immunocorp Sciences, Inc. CEP Class I 1990-08-29
K903306 TECHNICON CHEM I SYSTEM MAGNESIUM METHOD Technicon Instruments Corp. JGJ Class I 1990-08-29
K903094 STAT TEST HDL/CHOLESTEROL TEST KIT Diagnostic Resources, Inc. LBR Class I 1990-08-29
K901756 INTERJECTOR BLOOD COLLECTION DEVICE Bowman/Vector, Inc. JKA Class II 1990-08-29
K901131 YSI MODEL 1500 SPORT L-LACTATE ANALYZER Yellow Springs Instrument Co., Inc. KHP Class I 1990-08-27
K903095 IL THYROXINE (T4) ASSAY SYSTEM Instrumentation Laboratory CO KLI Class II 1990-08-23
K903218 IMX B12 Abbott Laboratories LIG Class II 1990-08-23
K903430 LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 Bio-Rad JJT Class I 1990-08-23
K903341 MAGNESIUM Catachem, Inc. JGJ Class I 1990-08-22
K903359 MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT Immunotech Corp. CGI Class I 1990-08-22
K902204 STANBIO CSF/URINE TOTAL PROTEIN TEST SET Stanbio Laboratory JIR Class I 1990-08-22

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