meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
57
Latest Decision
1990-03-09

Clearances · page 70 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K897160 COULTER GLUCOSE REAGENT Coulter Electronics, Inc. CFR Class II 1990-03-09
K897164 COULTER LD (LDH-L) REAGENT Coulter Electronics, Inc. CFJ Class II 1990-03-09
K897001 TOSOH AIA-PACK T3 Tosoh Corp. CDP Class II 1990-03-09
K896982 AIA-PACK T4 Tosoh Corp. KLI Class II 1990-03-09
K897163 COULTER ALT (GPT) REAGENT Coulter Electronics, Inc. CKA Class I 1990-03-09
K900120 ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL Roche Diagnostic Systems, Inc. LBR Class I 1990-03-09
K900036 IMMUNOTECH HDL-CHOLESTEROL TEST Immunotech Corp. LBS Class I 1990-03-09
K900775 NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM Bio-Rad JQW Class I 1990-03-09
K897071 ROCHE STANDARDS FOR THE COBAS ISE MODULE Roche Diagnostic Systems, Inc. JIX Class II 1990-03-09
K897138 AFFINITY(TM) HTSH(TM) Bd Becton Dickinson Vacutainer Systems Preanalytic JLW Class II 1990-03-09
K897159 COULTER TRIGLYCERIDES GPO REAGENT Coulter Electronics, Inc. CDT Class I 1990-03-09
K896482 PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT Pacific Biotech, Inc. LCX Class II 1990-03-06
K897036 IMMUNOTECH CHOLESTEROL TEST Immunotech Corp. CHH Class I 1990-03-06
K897161 COULTER URIC ACID REAGENT Coulter Electronics, Inc. KNK Class I 1990-03-01
K900300 LYTENING 2Z LYTENING SYSTEM 31 Baxter Healthcare Corp CEM Class II 1990-03-01
K900420 BICARBONATE REAGENTS PRODUCT #7713 & #7714 American Research Products Co. JFL Class II 1990-03-01
K897158 ABBOTT COMMANDER PARALLEL PROCESSING CENTER Abbott Laboratories JQW Class I 1990-03-01
K896465 CLP CK/LD ISOENZYME/IMMUNO CONTROL Creative Laboratory Products, Inc. JJT Class I 1990-03-01
K900250 AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781 American Research Products Co. CJE Class II 1990-03-01
K900621 FIAGEN(TM) HLH.S Cyberfluor, Inc. CEP Class I 1990-03-01
K900224 STAT FAX(TM)-2100 Awareness Technology, Inc. JJQ Class I 1990-03-01
K900147 MODIFIED DSL-2300 ACTH RIA Diagnostic Systems Laboratories, Inc. CKG Class II 1990-03-01
K896991 ENZYMUN TEST(R) TBK Boehringer Mannheim Corp. CEE Class II 1990-03-01
K897110 SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM Medisense, Inc. CEM Class II 1990-02-27
K896232 COBAS READY TOTAL BILIRUBIN REAGENT Roche Diagnostic Systems, Inc. CIG Class II 1990-02-27
K900579 AUTOREADER CALIBRATION TEST PLATE Bio-Tek Instruments, Inc. JJQ Class I 1990-02-27
K900259 DIRECT BILIRUBIN REAGENT Medical Analysis Systems, Inc. CIG Class II 1990-02-27
K896235 COBAS READY ALBUMIN REAGENT Roche Diagnostic Systems, Inc. CIX Class II 1990-02-27
K896236 COBAS READY BUN REAGENT Roche Diagnostic Systems, Inc. JGZ Class II 1990-02-27
K896875 POSITIVE AND NEGATIVE HCG SERUM CONTROLS Armkel, LLC JJX Class I 1990-02-26
K897150 LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT Toyo Jozo Co., Ltd. CHI Class I 1990-02-26
K896373 1400 SERIES EVIDENCE COLLECTION KIT Transidyne General Corp. GIM Class II 1990-02-26
K896951 SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM Medisense, Inc. CGA Class II 1990-02-26
K900251 REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 Helena Laboratories CEF Class I 1990-02-26
K896867 THYROID STIMULATING HORMONE-EIA-XT In Vitro Diagnostics, Inc. JLW Class II 1990-02-23
K897169 QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT Photec Diagnostics, Inc. CDT Class I 1990-02-23
K896954 ABBOTT SPECTRUM URIC ACID REAGENT KIT Abbott Laboratories KNK Class I 1990-02-23
K896812 CARBON DIOXIDE REAGENT Pointe Scientific, Inc., KHS Class II 1990-02-23
K897166 COULTER TOTAL PROTEIN REAGENT Coulter Electronics, Inc. CEK Class II 1990-02-23
K897165 COULTER AST (GOT) REAGENT Coulter Electronics, Inc. CIT Class II 1990-02-23
K896829 TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) Technicon Instruments Corp. JGT Class II 1990-02-23
K900372 BIOTRACK IMMUNOCHEMISTRY MONITOR Biotrack, Inc. JJQ Class I 1990-02-23
K896229 COBAS READY PROFILE 1 REAGENT STRIP Roche Diagnostic Systems, Inc. CIT Class II 1990-02-16
K896521 MODIFIED PARAMAX URIC ACID REAGENT Baxter Healthcare Corp KNK Class I 1990-02-16
K896231 COBAS READY TRIGLYCERIDE REAGENT Roche Diagnostic Systems, Inc. CDT Class I 1990-02-16
K896170 REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 Helena Laboratories JHT Class II 1990-02-16
K896233 COBAS READY LIVER PROFILE REAGENT STRIP Roche Diagnostic Systems, Inc. CIT Class II 1990-02-16
K896238 COBAS READY AST REAGENT Roche Diagnostic Systems, Inc. CIS Class II 1990-02-16
K896230 COBAS READY TOTAL PROTEIN REAGENT Roche Diagnostic Systems, Inc. CEK Class II 1990-02-16
K896239 COBAS READY CHOLESTEROL REAGENT Roche Diagnostic Systems, Inc. CHH Class I 1990-02-16
K896587 MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. JHI Class II 1990-02-16
K896440 KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT Kenlor Industries, Inc. JIR Class I 1990-02-16
K896240 COBAS READY CK REAGENT Roche Diagnostic Systems, Inc. JHY Class II 1990-02-16
K895951 CHOLESTEROL TEST KIT Elite Technology, Inc. CHH Class I 1990-02-16
K896237 COBAS READY ALT REAGENT Roche Diagnostic Systems, Inc. CKD Class I 1990-02-16
K896234 COBAS READY STAT PROFILE REAGENT STRIP Roche Diagnostic Systems, Inc. CKA Class I 1990-02-16
K900280 CENTRIPREP 100 Amicon, Inc. JJP Class I 1990-02-16
K896228 COBAS READY CARDIO PROFILE REAGENT STRIP Roche Diagnostic Systems, Inc. CIT Class II 1990-02-16
K896845 RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT Reagents Applications, Inc. CDL Class II 1990-02-16
K896241 COBAS READY LDH REAGENT Roche Diagnostic Systems, Inc. CFJ Class II 1990-02-16
K896227 COBAS READY URIC ACID REAGENT Roche Diagnostic Systems, Inc. KNK Class I 1990-02-16
K896258 CO2 REAGENT (340 NM) Sigma Chemical Co. KHS Class II 1990-02-13
K896316 EOS IONIZED CALCIUM TEST CARD Eos Technology Corp. JFP Class II 1990-02-13
K896866 LUTEINIZING HORMONE-EIA-XT In Vitro Diagnostics, Inc. CEP Class I 1990-02-13
K896901 ENZYMUN TEST R HCG Boehringer Mannheim Corp. JHI Class II 1990-02-08
K896686 AMRESCO CREATININE REAGENT #4316100 American Research Products Co. CGX Class II 1990-02-08
K896650 AMYLASE REAGENT Sigma Chemical Co. JFJ Class II 1990-02-08
K896900 ENZYMUN TEST R T3 Boehringer Mannheim Corp. CDP Class II 1990-02-08
K900216 COULTER ALP (ALK PHOS) REAGENT Coulter Corp. CJE Class II 1990-02-08
K900215 COULTER PHOSPHORUS REAGENT Coulter Corp. CEO Class I 1990-02-08
K892642 DADE(R) TDM CONTROL Baxter Healthcare Corp JJY Class I 1990-02-02
K896590 CARBON DIOXIDE REAGENT Pointe Scientific, Inc., KHS Class II 1990-02-01
K895317 AVL MODEL 995HB PH/BLOOD GAS ANALYZER Avl Scientific Corp. CHL Class II 1990-02-01
K896865 VITRO T4-EIA-XT In Vitro Diagnostics, Inc. KLI Class II 1990-01-30
K896642 MODIFIED LH ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. CEP Class I 1990-01-30
K896514 QS90 SMOOTH E ARTERIAL BLOOD SAMPLER Radiometer America, Inc. GIM Class II 1990-01-23
K900028 ALLERCOAT MICROPLATE SYSTEM Kallestad Diag, A Div. of Erbamont, Inc. JJQ Class I 1990-01-22
K896916 CLINISTAT TOTAL PROTEIN REAGENT TEST Heraeus Kulzer, Inc. CEK Class II 1990-01-19
K900014 MILENIA (TM) TSH Diagnostic Products Corp. JLW Class II 1990-01-19
K895862 CLP NORMAL LIPID CONTROL Creative Laboratory Products, Inc. JJY Class I 1990-01-19
K896162 ABBOTT IMX PROLACTIN Abbott Laboratories CFT Class I 1990-01-19
K896808 IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I Nichols Institute Diagnostics CFL Class I 1990-01-19
K895905 LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3 Bio-Rad JJY Class I 1990-01-18
K896910 CLINISTAT ALBUMIN REAGENT TEST Miles Diagnostics Div. CIX Class II 1990-01-18
K895649 COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. Ventrex Laboratories, Inc. JIT Class II 1990-01-18
K895648 COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. Ventrex Laboratories, Inc. JIT Class II 1990-01-18
K896925 T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT In Vitro Diagnostics, Inc. KHQ Class II 1990-01-18
K896572 REP(TM) SPE PLUS-30 PROCEDURES Helena Laboratories CFP Class I 1990-01-11
K895999 PHOSPHORUS American Monitor Corp. CEO Class I 1990-01-11
K895952 TRIGLYCERIDES TEST KIT Elite Technology, Inc. CDT Class I 1990-01-11
K895717 SODIUM AND POTASSIUM STANDARD Data Medical Associates, Inc. JIX Class II 1990-01-11
K896864 FOLLICLE STIMULATING HORMONE-EIA-XT In Vitro Diagnostics, Inc. CGJ Class I 1990-01-11
K894011 TOTAL GALACTOSE Alpkem Corp. KQP Class II 1990-01-11
K896454 CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS Boehringer Mannheim Corp. JIL Class II 1990-01-11
K896000 ASPARTATE AMINOTRANFERASE (AST) American Monitor Corp. CIT Class II 1990-01-11
K896246 CLP COMPREHENSIVE LIPID CONTROL-LR Creative Laboratory Products, Inc. JJY Class I 1990-01-10
K895282 CHARISE CHARLES REAGENT STRIPS Lee Import Domestic Consulting JIL Class II 1990-01-10
K896247 CLP COMPREHENSIVE LIPID CONTROL-HR Creative Laboratory Products, Inc. JJY Class I 1990-01-10
K896522 DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY Casco Standards JJY Class I 1990-01-02
K896526 LYTENING(TM) 5, LYTENING(TM) SYSTEM 30 Baxter Healthcare Corp JGS Class II 1990-01-02

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