meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
62
Latest Decision
1992-01-15

Clearances · page 63 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K913809 HY-PREP SYSTEM Hyperion, Inc. JQW Class I 1992-01-15
K914811 IL TEST(TM) HDL CHOLESTEROL Instrumentation Laboratory CO LBR Class I 1992-01-09
K914255 LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2 Bio-Rad JJY Class I 1992-01-09
K914820 DSL INSULIN RIA (DSL 1600) Diagnostic Systems Laboratories, Inc. CFP Class I 1992-01-09
K914901 VACUTAINER KIT Abbott Laboratories GIM Class II 1992-01-08
K915087 DMI BLOD GAS ANALYZER/CARTRIDGE Diamond Medical, Inc. CHL Class II 1992-01-08
K915213 CORVAC BLOOD COLLECTION TUBE Sherwood Medical Co. GIM Class II 1992-01-08
K915427 ORS-1000 Mnlase, Inc. JRM Class I 1992-01-07
K914463 ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42 Em Diagnostic Systems, Inc. CIT Class II 1992-01-03
K915399 QUALICHECK 4 Radiometer America, Inc. JJS Class I 1992-01-02
K913315 BIO-RAD TOTAL PROTEIN TEST KIT Bio-Rad CEF Class I 1992-01-02
K914903 QUICKSTART UREA NITROGEN Em Diagnostic Systems, Inc. CDN Class II 1991-12-31
K914990 ADVANCE(R) PREGNANCY TEST Ortho Pharmaceutical Corp. LCX Class II 1991-12-23
K912028 URIC ACID (URICASE) REAGENT, UNIVERSAL Enzyme Technology, Inc. KNK Class I 1991-12-18
K914794 TECHNICON CHEM 1 PLASMA GLUCOSE Heraeus Kulzer, Inc. CFR Class II 1991-12-18
K913565 ABBOTT QUICKSTART CHOLESTEROL TEST Em Diagnostic Systems, Inc. CHH Class I 1991-12-18
K915208 FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057 Medix Biotech, Inc. CGJ Class I 1991-12-18
K915077 SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, Beckman Instruments, Inc. CGX Class II 1991-12-18
K915191 RAI-TROL ELEVATED LIPIDS CONTROL Reagents Applications, Inc. JJY Class I 1991-12-18
K914835 LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY London Diagnostics, Inc. CEC Class II 1991-12-17
K915197 PRECISE TM HCG Becton Dickinson Advanced Diagnostics JHI Class II 1991-12-17
K915200 PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA Becton Dickinson Advanced Diagnostics JHI Class II 1991-12-16
K914361 CREATINE KINASE MB TEST ITEM NUMBER 5A46 Em Diagnostic Systems, Inc. CGS Class II 1991-12-13
K913963 IMMUCHEM NEONATAL TSH-MP ELISA Icn Biomedicals, Inc. JLW Class II 1991-12-13
K914917 DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIX Class II 1991-12-13
K914841 CHROMATOGRAPHY CLINICAL USE 75JQR Millipore Corp. KIE Class I 1991-12-10
K915194 CEDIA T4 Boehringer Mannheim Corp. KLI Class II 1991-12-09
K914873 DIAZO COLORIMETRY, BILIRUBIN Pointe Scientific, Inc., CIG Class II 1991-12-04
K914810 EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER Medica Corp. JGS Class II 1991-12-04
K914560 STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL Ppg Industries, Inc. CHL Class II 1991-11-29
K914508 DIMENSION(R) LACTIC ACID METHOD E.I. Dupont DE Nemours & Co., Inc. KHP Class I 1991-11-27
K914511 TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL Technicon Instruments Corp. LBS Class I 1991-11-27
K914906 AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT Bio-Tek Instruments, Inc. JJQ Class I 1991-11-27
K914888 TECHNICON CHEM 1(TM) SYST (GEN2 SYST) Technicon Instruments Corp. CIX Class II 1991-11-27
K913807 REP(R) SPE TEMPLATE 30, 16, & 8 Helena Laboratories CEF Class I 1991-11-27
K914486 COULTER CARBON DIOXIDE REAGENT Coulter Corp. KHS Class II 1991-11-27
K914025 TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) Technicon Instruments Corp. CIT Class II 1991-11-22
K914018 ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 Em Diagnostic Systems, Inc. CDT Class I 1991-11-22
K914464 ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 Em Diagnostic Systems, Inc. CKA Class I 1991-11-22
K914750 ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR Roche Diagnostic Systems, Inc. JIX Class II 1991-11-22
K913921 ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 Em Diagnostic Systems, Inc. CJE Class II 1991-11-22
K914619 CVM Ciba Corning Diagnostics Corp. JJY Class I 1991-11-22
K914731 TRACE GAMMA GT-SS REAGENT Trace Scientific , Ltd. JQB Class I 1991-11-19
K914510 CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY Beckman Instruments, Inc. JFN Class II 1991-11-19
K912937 SR1 FREE T4 ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. CEC Class II 1991-11-19
K914696 MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 Medix Biotech, Inc. JHI Class II 1991-11-13
K913371 TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL Creative Laboratory Products, Inc. JIT Class II 1991-11-08
K913938 OPUS(R) LH TEST SYSTEM Pb Diagnostic Systems, Inc. CEP Class I 1991-11-07
K913357 ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST Lifescan, Inc. CGA Class II 1991-11-07
K914609 TRIGLYCERIDES REAGENT SET Sterling Diagnostics, Inc. CDT Class I 1991-11-07
K913764 ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 Em Diagnostic Systems, Inc. JGJ Class I 1991-11-05
K914039 SODIUM REAGENT SET Sterling Diagnostics, Inc. CEI Class II 1991-10-31
K912807 ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 Em Diagnostic Systems, Inc. JFY Class II 1991-10-31
K914040 PHOSPHOLIPID REAGENT SET Sterling Diagnostics, Inc. JNT Class I 1991-10-30
K914469 CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL Cholestech Corp. CHH Class I 1991-10-30
K913058 REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 Helena Laboratories CEF Class I 1991-10-30
K913590 MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER Dynatech Laboratories, Inc. JJQ Class I 1991-10-25
K913466 ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20 Em Diagnostic Systems, Inc. CIG Class II 1991-10-25
K913434 VENTREX COATED TUBE INTACT PTH Ventrex Laboratories, Inc. CEW Class II 1991-10-25
K913646 CIBA CORNING ACS T3 IMMUNOASSAY Ciba Corning Diagnostics Corp. CDD Class II 1991-10-25
K914240 CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF Unipath , Ltd. JHI Class II 1991-10-25
K913349 STAMBI-CK Intl. Immunoassay Laboratories, Inc. JHW Class II 1991-10-23
K914462 SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) Serono-Baker Diagnostics, Inc. JLS Class I 1991-10-23
K914261 ABBOTT QUICKSTART LD-1,#5A30 Em Diagnostic Systems, Inc. JGF Class II 1991-10-21
K913585 LIPASE LINEARITY CONTROL Creative Laboratory Products, Inc. JJX Class I 1991-10-21
K913399 QBC E-Z PREP Bd Becton Dickinson Vacutainer Systems Preanalytic JKA Class II 1991-10-18
K914304 FIRST RESPONSE(R) ONE-STEP Armkel, LLC LCX Class II 1991-10-17
K914254 HOMECLINIC ONE STEP PREGNANCY TEST Vanguard Biomedical Corp. LCX Class II 1991-10-17
K910970 MARKSMAN ARTERIAL BLOOD GAS SYRINGE Martech Medical Products, Inc. JKA Class II 1991-10-15
K914129 DIFF SAFE Marshall Levinson JKA Class II 1991-10-11
K914262 ABBOTT QUICKSTART LDH,#5A31 Em Diagnostic Systems, Inc. CFJ Class II 1991-10-11
K913927 IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST Instrumentation Laboratory CO CHL Class II 1991-10-11
K914253 PROCLINIC ONE STEP PREGNANCY TEST Vanguard Biomedical Corp. JHI Class II 1991-10-11
K914303 TARGET(TM)-HOG V-Tech, Inc. JHI Class II 1991-10-11
K913225 URINE/CSF MICROPROTEIN REAGENT Intersect Systems, Inc. CEK Class II 1991-10-11
K913307 ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21 Em Diagnostic Systems, Inc. CIG Class II 1991-10-11
K914202 BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE Baxter Diagnostics, Inc. JJQ Class I 1991-10-11
K913025 ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 Em Diagnostic Systems, Inc. CJW Class II 1991-10-09
K913705 ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 Em Diagnostic Systems, Inc. CFM Class I 1991-10-09
K913978 TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE Beckman Instruments, Inc. CEK Class II 1991-10-09
K912698 AFFINITY FREE T4 TEST SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic CEC Class II 1991-10-07
K913567 WELLPREP 1 Denley Instruments, Inc. JQW Class I 1991-10-04
K913806 YSI MODEL 2300 STAT PLUS Ysis, Inc. CGA Class II 1991-10-02
K914068 ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST Em Diagnostic Systems, Inc. CIT Class II 1991-10-02
K914069 REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 Medical Analysis Systems, Inc. MSJ Class I 1991-10-02
K914107 PROLACTIN IRMA IMMUNOMAG Pantex, Div. Bio-Analysis, Inc. CFT Class I 1991-09-30
K913663 AIA-PACK T-U Tosoh Corp. KHQ Class II 1991-09-30
K913840 MICROTAK PLUS Syva Co. JJQ Class I 1991-09-30
K903564 MEDISENSOR 2001 Medtest Systems, Inc. JGS Class II 1991-09-30
K913706 ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 Em Diagnostic Systems, Inc. KNK Class I 1991-09-27
K913298 AIA-PACK CK-MB Tosoh Corp. JHX Class II 1991-09-27
K912852 STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO Baxter Healthcare Corp JLW Class II 1991-09-27
K913920 ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37 Em Diagnostic Systems, Inc. CIX Class II 1991-09-27
K913133 CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) Bionostics, Inc. JJY Class I 1991-09-27
K913162 ENZYMUN-TEST ESTRADIOL Boehringer Mannheim Corp. CHP Class I 1991-09-27
K912499 KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST King Diagnostics, Inc. CHH Class I 1991-09-27
K914033 CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST Cholestech Corp. JGY Class I 1991-09-27
K913130 STRATUS IINTELLECT IMMUNOASSAY SYSTEM Baxter Healthcare Corp KHO Class I 1991-09-27
K913777 SELF-CONTAINED SURGICAL SLUSH FREEZER Taylor Corp. JRM Class I 1991-09-25
K912717 J&S UIBC REAGENTS J.S. Medical Assoc. JMO Class I 1991-09-25

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