meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
56
Latest Decision
1991-09-25

Clearances · page 64 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K912616 TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES Technicon Instruments Corp. KLI Class II 1991-09-25
K913398 RAICHEM(TM) CREATINE KINASE-MB REAGENT Reagents Applications, Inc. CGS Class II 1991-09-25
K913224 LIPID LINEARITY CONTROLS Creative Laboratory Products, Inc. JJY Class I 1991-09-25
K913792 HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL Hichem Diagnostics JJX Class I 1991-09-25
K913196 KODAK EKTACHEM DT SLIDES (LIPASE) Eastman Kodak Company CHT Class I 1991-09-25
K912716 J&S IRON REAGENTS J.S. Medical Assoc. JMO Class I 1991-09-25
K913346 QUANTIMETRIX AMMONIA CONTROLS Quantimetrix Corp. JJX Class I 1991-09-25
K912749 REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B Medical Analysis Systems, Inc. MSJ Class I 1991-09-23
K913846 ABBOTT QUICKSTART ALANINE AMINOTRANSFER Em Diagnostic Systems, Inc. CKA Class I 1991-09-19
K913687 CHEM-CHEX Streck Laboratories, Inc. JJY Class I 1991-09-19
K913922 ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 Em Diagnostic Systems, Inc. JMO Class I 1991-09-19
K913707 ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28 Em Diagnostic Systems, Inc. CGX Class II 1991-09-18
K911912 SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) Serono-Baker Diagnostics, Inc. KHQ Class II 1991-09-18
K913615 URINARY/CSF PROTEIN Boehringer Mannheim Corp. JGQ Class II 1991-09-13
K912561 NOVA 13 ANALYZER Nova Biomedical Corp. CGZ Class II 1991-09-11
K913295 OPUS(R) PLUS ANALYZER Pb Diagnostic Systems, Inc. JJQ Class I 1991-09-11
K912806 ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22 Em Diagnostic Systems, Inc. KHS Class II 1991-09-11
K913496 CHOLINESTERASE LINEARITY CONTROL Creative Laboratory Products, Inc. JJX Class I 1991-09-11
K913858 AMYLASE REAGENT (PROCEDURE 577) Sigma Diagnostics, Inc. JFJ Class II 1991-09-11
K912368 IMX SELECT ANALYZER Abbott Laboratories JJQ Class I 1991-09-11
K913493 AIA-PACK FT4 Tosoh Corp. CEC Class II 1991-09-10
K912732 FIRST CHOICE(TM) Polymer Technology Corp. CGA Class II 1991-09-10
K912718 ENZYME LINEARITY CONTROL Phoenix Diagnostics, Inc. JJY Class I 1991-09-06
K912844 KODAK EKTACHEM DTII SYSTEM Eastman Kodak Company JJE Class I 1991-09-04
K910806 METROLAB MODEL 1500 Laboratorio Rodriguez Corswant S.R.L. JJQ Class I 1991-08-30
K913664 ROSYS MODELS 100 AND 200 Packard Instrument Co., Inc. JQW Class I 1991-08-30
K912439 TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET Hybritech, Inc. JJX Class I 1991-08-28
K912212 PROACT CHOLESTEROL SYSTEMS Boehringer Mannheim Corp. CHH Class I 1991-08-28
K913197 KODAK EKTACHEM DT SLIDES (LAC) Eastman Kodak Company KHP Class I 1991-08-26
K913091 BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY American Laboratory Products Co., Ltd. KQN Class II 1991-08-26
K913195 KODAK EKTACHEM DT SLIDES (ALB) Eastman Kodak Company CIX Class II 1991-08-26
K911809 NEW-VENT Concord/Portex JKA Class II 1991-08-26
K913330 URINE COLLECTION KIT/DEVICE Medical Implements, Inc. KHP Class I 1991-08-26
K913236 STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Healthcare Corp DHA Class II 1991-08-16
K913122 DIRECTIGEN 1-2-3(TM) HCG TEST Quidel Corp. JHI Class II 1991-08-16
K911217 SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) Serono-Baker Diagnostics, Inc. KLI Class II 1991-08-16
K912823 HIGH DENSITY LIPOPROTEIN CHOLESTEROL Creative Laboratory Products, Inc. LBR Class I 1991-08-16
K911692 ENZYMATICS, INC., TOTAL CHOLESTEROL TEST Enzymatics C/O Burditt,Bowles,Radzius & Ruberry CHH Class I 1991-08-16
K913280 OPUS(R) PROLACTIN TEST SYSTEM Pb Diagnostic Systems, Inc. CFT Class I 1991-08-16
K912455 DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL Baxter Healthcare Corp JJY Class I 1991-08-12
K912541 MILENIA TOTAL T4, CATALOG: MKT41,5 Diagnostic Products Corp. CDX Class II 1991-08-12
K913105 REFLOTRON CREATININE TEST TABS Boehringer Mannheim Corp. JFY Class II 1991-08-12
K912850 SHBG Wien Laboratories, Inc. CDZ Class I 1991-08-12
K912795 BIOTROL UIBC REAGENT Biotrol, USA, Inc. JMO Class I 1991-08-12
K912809 ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 Em Diagnostic Systems, Inc. CEO Class I 1991-08-12
K912804 FSH IRMA IMMUNOMAG Pantex, Div. Bio-Analysis, Inc. CGJ Class I 1991-08-12
K913124 ROCHE REAGENT FOR AMMONIA Roche Diagnostic Systems, Inc. JIF Class I 1991-08-12
K912583 MAGIC LITE TSH (HS) IMMUNOASSAY Ciba Corning Diagnostics Corp. JLW Class II 1991-08-12
K911985 LUMATAG T4 CHEMILUMINESCENCE ASSAY London Diagnostics, Inc. CDX Class II 1991-08-02
K912912 SYNERMED SERUM IRON-600 REAGENT KIT Synermed, Inc. CFM Class I 1991-07-30
K912136 CHOLESTECH LIPID MONITORING SYS. Cholestech Corp. CHH Class I 1991-07-30
K912858 LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY London Diagnostics, Inc. CFL Class I 1991-07-30
K912603 REP ALP-15, 8, & 4 KITS Helena Laboratories CIN Class II 1991-07-30
K912725 TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL Creative Laboratory Products, Inc. JJY Class I 1991-07-30
K912808 ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15 Em Diagnostic Systems, Inc. CFR Class II 1991-07-30
K912810 ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13 Em Diagnostic Systems, Inc. CEK Class II 1991-07-30
K912917 MILENIA ESTRADIOL Diagnostic Products Corp. CHP Class I 1991-07-30
K912959 MICROTRAK MANAGER Syva Co. JJQ Class I 1991-07-26
K913024 ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST Em Diagnostic Systems, Inc. JQB Class I 1991-07-26
K912825 MAGNESIUM ASSAY KIT, CAT.# 100-12 Diagnostic Chemicals, Ltd. (Usa) JGJ Class I 1991-07-26
K912036 ROBOTIC SAMPLE PROCESSOR Tecan U.S., Ltd. JQW Class I 1991-07-26
K912318 ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) Serono-Baker Diagnostics, Inc. CHP Class I 1991-07-25
K912316 QUIKPAC-II ONE STEP PREGNANCY HOME TEST Syntron Bioresearch, Inc. LCX Class II 1991-07-24
K912733 AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT Amersham Corp. CIG Class II 1991-07-22
K912024 AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) Wako Chemicals USA, Inc. JJE Class I 1991-07-19
K912513 ELECTROLYTE CONTROL Verichem Laboratories, Inc. JJR Class I 1991-07-19
K912543 MICRO ALBUMIN EIA TEST KIT Immuno Diagnostic Center, Inc. JIR Class I 1991-07-19
K911838 ROCHE REAGENT FOR C02 Roche Diagnostic Systems, Inc. CHS Class II 1991-07-19
K911826 IMMUNOCARD HCG ONE STEP (I-S) TEST KIT Disease Detection International, Inc. JHI Class II 1991-07-19
K912246 TARGET MICROALBUMINURIA TEST Texas Immunology, Inc. JIR Class I 1991-07-19
K912536 CALCITONIN KIT MITSUBISHI YUKA Mitsubishi Yuka America, Inc. JKR Class II 1991-07-18
K912251 KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST King Diagnostics, Inc. CFR Class II 1991-07-18
K911906 MAGNETIC HDL CHOLESTEROL TEST Reference Diagnostics, Inc. LBR Class I 1991-07-18
K911624 VISION BG TEST STRIP British-American Medical, Inc. CGA Class II 1991-07-17
K912569 SYNERMED PHOSPHORUS REAGENT KIT Synermed, Inc. CEO Class I 1991-07-17
K912440 ULTRA BLOOD GLUCOSE MONITORING SYSTEM Home Diagnostics, Inc. CGA Class II 1991-07-17
K912441 LINEARITY TEST KITS Boehringer Mannheim Corp. JJY Class I 1991-07-17
K912648 ISE/NA+ Boehringer Mannheim Corp. JGS Class II 1991-07-17
K911866 TRACE TOTAL/DIRECT BILIRUBIN REAGENT Trace Scientific , Ltd. CIG Class II 1991-07-17
K912647 ISE/CI- Boehringer Mannheim Corp. CGZ Class II 1991-07-17
K912766 AMERLITE CK-MB ASSAY Amersham Corp. JHY Class II 1991-07-17
K912386 REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 Helena Laboratories CEF Class I 1991-07-17
K912560 NOVA 12 ANALYZER Nova Biomedical Corp. JGS Class II 1991-07-17
K912649 ISE/K+ Boehringer Mannheim Corp. CEM Class II 1991-07-15
K912231 PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT Intl. Immunoassay Laboratories, Inc. JHW Class II 1991-07-08
K912413 CHEM-LINK DATA BASE MANAGER Technicon Instruments Corp. JJQ Class I 1991-07-01
K912534 IMX HCG Abbott Laboratories JHI Class II 1991-07-01
K912519 AMYLASE REAGENT Genzyme Corp. JFJ Class II 1991-07-01
K912387 I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK I-Stat Corp. JGS Class II 1991-07-01
K911801 KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON Gds Technology, LLC JIN Class I 1991-07-01
K912373 KETO-340 II Ihara Medics U.S., Inc. JIN Class I 1991-07-01
K912535 IMX TOTAL B-HCG Abbott Laboratories JHI Class II 1991-07-01
K912559 NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER Nova Biomedical Corp. JGS Class II 1991-07-01
K912026 DELFIA(R) 17 -OH-PROGESTERON KIT Pharmacia Diagnostics, Inc. JLX Class I 1991-06-25
K911047 OBA(TM) SERUM HCG ASSAY Adeza Biomedical JHI Class II 1991-06-24
K911634 MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST Immunotech Corp. CEC Class II 1991-06-24
K911045 OBA(TM) READER Adeza Biomedical JJQ Class I 1991-06-24
K911638 SYRINGE TIP CAP Concord/Portex JKA Class II 1991-06-21
K911796 IMMULITE(TM) HCG Cirrus Diagnostics, Inc. DHA Class II 1991-06-20
K912324 NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic JLW Class II 1991-06-20

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