meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
62
Latest Decision
1986-03-14

Clearances · page 90 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K860253 AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) Amersham Corp. CHO Class II 1986-03-14
K860559 ANDROSTENEDIONE 125I KIT BY RIA Immuchem Corp. CIZ Class I 1986-03-14
K855091 CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS Sen Tech Medical Corp. CDS Class II 1986-03-14
K860476 ACID PHOSPHATASE REAGENT SET Sterling Diagnostics, Inc. CKE Class II 1986-03-05
K860221 ENCORE PROLACTIN REAGENT Hybritech, Inc. CFT Class I 1986-03-05
K860490 MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY Medix Biotech, Inc. JHI Class II 1986-03-05
K860057 ABL330 ACID BASE LABORATORY Radiometer America, Inc. CHL Class II 1986-03-05
K855079 NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 Em Diagnostic Systems, Inc. CIG Class II 1986-03-05
K860542 TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. JHI Class II 1986-03-05
K855188 CPK (UV) REAGENT KIT Technostics Intl. JHS Class II 1986-03-05
K854723 SKD ELECTROCHEMICAL SYSTEM (ECS) Smithkline Diagnostics, Inc. CEM Class II 1986-03-05
K860530 AMYLASE REAGENT SET (MODIFIED CARAWAY) Sterling Diagnostics, Inc. CJA Class II 1986-02-28
K855173 DELFIA TM HLH KIT Lkb Instruments, Inc. CEP Class I 1986-02-28
K860228 SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA Boots-Celltech Diagnostics, Inc. CFL Class I 1986-02-28
K860349 LACTATE DEHYDROGENASE (LDH) REAGENT SET Sterling Diagnostics, Inc. CFH Class II 1986-02-28
K854094 IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS Immuchem Corp. JLS Class I 1986-02-28
K855108 RASCAL ANESTHESIA RESPIRATORY GAS ANALYZOR Biomaterials International, Inc. JJQ Class I 1986-02-21
K860257 DIRECT BILIRUBIN Pointe Scientific, Inc., CIG Class II 1986-02-21
K860135 EASY-TEST UREA (BUN) REAGENT Em Diagnostic Systems, Inc. CDQ Class II 1986-02-21
K854679 PHOTIC-100 SPECTROPHOTOMETER Future Impex Corp. JJQ Class I 1986-02-20
K855199 PARAMAX COMPREHENSIVE CALIBRATOR American Dade JIX Class II 1986-02-19
K860130 TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT Cambridge Medical Technology CDZ Class I 1986-02-19
K860111 URIC ACID REAGENT SET Technostics Intl. LFQ Class I 1986-02-19
K855164 ENZYNATIC TRIGLYCERIDES REAGENT SET Sterling Diagnostics, Inc. CDT Class I 1986-02-19
K860340 SERUM ALBUMIN (BCG) REAGENT SET Sterling Diagnostics, Inc. CIX Class II 1986-02-19
K860453 ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 Sigma Diagnostics, Inc. JJX Class I 1986-02-19
K855190 MAGNESIUM REAGENT SET Technostics Intl. JGJ Class I 1986-02-18
K854670 TERUMO SENSIBEAD EIG HCG KIT Terumo Medical Corp. JHJ Class II 1986-02-13
K854945 MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY Ciba Corning Diagnostics Corp. CDD Class II 1986-02-11
K860419 UREA NITROGEN REAGENT SET Sterling Diagnostics, Inc. CDW Class II 1986-02-11
K860251 AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA Amersham Corp. CEC Class II 1986-02-11
K860418 CREATININE REAGENT SET Sterling Diagnostics, Inc. CGX Class II 1986-02-11
K860421 STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY American Dade CDX Class II 1986-02-11
K860142 URIC ACID REAGENT SET (COLORIMETRIC) Sterling Diagnostics, Inc. LFQ Class I 1986-02-11
K860351 ALKALINE PHOSPHATASE REAGENT SET Sterling Diagnostics, Inc. CIO Class II 1986-02-11
K855149 COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER Hyperion, Inc. JJQ Class I 1986-02-11
K860215 MAGNESIUM REAGENT SET Sterling Diagnostics, Inc. JGJ Class I 1986-02-11
K855080 EMDS GLUCOSE TEST PACK ITEM 67656/95 Em Diagnostic Systems, Inc. LFR Class II 1986-02-11
K860110 GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET Technostics Intl. CKA Class I 1986-02-11
K860341 TOTAL PROTEIN (BIURET) REAGENT SET Sterling Diagnostics, Inc. CEK Class II 1986-02-11
K860021 DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM E.I. Dupont DE Nemours & Co., Inc. JJE Class I 1986-02-11
K860252 AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA Amersham Corp. CDP Class II 1986-02-11
K860096 CPK REAGENT SET (COLORIMETRIC) Sterling Diagnostics, Inc. CGS Class II 1986-02-11
K860213 ALBUMIN REAGENT KIT Bio-Analytics Laboratories, Inc. CIX Class II 1986-02-11
K860044 CALCIUM (CPC) REAGENT SET Sterling Diagnostics, Inc. CIC Class II 1986-02-11
K860172 QWIKSPIN (TM) Norfolk Scientific, Inc. JQC Class I 1986-02-11
K860143 URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE Reagent Laboratory, Inc. JJP Class I 1986-02-10
K854406 TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 Tecan U.S., Ltd. JQW Class I 1986-02-10
K854971 V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT V-Tech, Inc. KLI Class II 1986-02-06
K860134 EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT Em Diagnostic Systems, Inc. CJE Class II 1986-02-06
K860109 ENZYMATIC UREA NITROGEN REAGENT SET Technostics Intl. CDQ Class II 1986-02-06
K860154 BUN (ENZYMATIC BERTHELOT) REAGENT SET Sterling Diagnostics, Inc. CDL Class II 1986-02-06
K855169 T3 UPTAKE RADIOIMMUNOASSAY KIT Cambridge Medical Technology KHQ Class II 1986-02-06
K860029 LDH (OPTIMIZED) REAGENT Sigma Chemical Co. CFJ Class II 1986-02-06
K854936 EIA PROCESSOR Abbott Laboratories JJE Class I 1986-02-06
K854805 ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM Nichols Institute Diagnostics CFT Class I 1986-01-28
K854675 DSL ANDROSTENEDIONE RIA (DSL #4200) Diagnostic Systems Laboratories, Inc. JLS Class I 1986-01-28
K854958 HCG RIA TEST SYSTEM Monobind JHI Class II 1986-01-28
K855028 TOTAL CHOLESTEROL REAGENT SET Sterling Diagnostics, Inc. CHH Class I 1986-01-28
K860080 OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM Olympus Corp. JJE Class I 1986-01-24
K860112 TOTAL LIPIDS REAGENT SET Technostics Intl. CFD Class I 1986-01-24
K855033 T-3 UPTAKE/RIASSAY Ria Diagnostics KHQ Class II 1986-01-24
K855185 GLUCOSE REAGENT SET Technostics Intl. CGE Class II 1986-01-22
K855196 CLEANING REAGENT KIT PRODUCT NO 88194 Hi Chem, Inc. JJE Class I 1986-01-22
K855041 CALCIUM LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. CIC Class II 1986-01-22
K854245 SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV Sigma Diagnostics, Inc. KQN Class II 1986-01-22
K854673 DSL ANDROSTENEDIONE RIA (DSL # 4200) Diagnostic Systems Laboratories, Inc. CIZ Class I 1986-01-22
K855056 EMDS TOTAL CK TEST PACK-#67670/95 Em Diagnostic Systems, Inc. CGS Class II 1986-01-22
K854783 TRIGLYCERIDE'S TEST (TRIGLI-CINET) Sclavo, Inc. CDT Class I 1986-01-22
K855040 SERALYZER TOTAL BILIRUBIN CALIBRATORS Miles Laboratories, Inc. JIS Class II 1986-01-22
K855157 LACTIC DEHYDROGENASE (VV) REAGENT SET Technostics Intl. CFJ Class II 1986-01-21
K855006 CANTROL CK/MB CONTROL Canyon Diagnostics, Inc. JJT Class I 1986-01-17
K854426 KODAK EKTACHEM HDL CHOLESTEROL KIT Eastman Kodak Company CHH Class I 1986-01-17
K855225 ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL Boehringer Mannheim Corp. JJX Class I 1986-01-17
K854766 CREATININE PAP Boehringer Mannheim Corp. JFY Class II 1986-01-17
K854931 CANTROL ELECTROPHORESIS CONTROL Canyon Diagnostics, Inc. JJY Class I 1986-01-17
K854946 TDXR 5-HIAA (URINE) Abbott Laboratories CDA Class I 1986-01-17
K854798 T-4 RIASSAY Ria Diagnostics CDX Class II 1986-01-15
K855153 GLUCOSE (UV HEXOKIASE) REAGENT SET Technostics Intl. CFR Class II 1986-01-14
K855186 GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET Technostics Intl. JPZ Class I 1986-01-14
K855193 CREATININE REAGENT SET Technostics Intl. CGX Class II 1986-01-14
K855154 INORGANIC PHOSPHORUS REAGENT SET Technostics Intl. CEO Class I 1986-01-14
K855159 LACTIC DEHYDROGENASE REAGENT SET Technostics Intl. CFJ Class II 1986-01-14
K855195 DIRECT & TOTAL BILIRUBIN SET Technostics Intl. CIG Class II 1986-01-14
K855192 ALKALINE PHOSPHATASE REAGENT SET Technostics Intl. CIO Class II 1986-01-14
K855158 ALBUMIN REAGENT SET Technostics Intl. CIX Class II 1986-01-14
K855189 GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET Technostics Intl. CIQ Class II 1986-01-14
K855194 GLUCOSE OXIDASE REAGENT SET Technostics Intl. CGA Class II 1986-01-14
K854982 VISION SGOT (AST) Abbott Laboratories CIT Class II 1986-01-14
K855191 TOTAL PROTEIN REAGENT SET Technostics Intl. CEK Class II 1986-01-14
K855187 ENZYMATIC CHOLESTROL REAGENT SET Technostics Intl. CHH Class I 1986-01-14
K854717 NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 Nobel Scientific Industries, Inc. CEK Class II 1986-01-14
K855156 GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET Technostics Intl. JPZ Class I 1986-01-14
K854059 MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO Bioclinical Systems, Inc. JHI Class II 1986-01-13
K854789 RANGE-CHEK American Monitor Corp. JJY Class I 1986-01-13
K854768 TERUMO SENSIBEAD EIA HPRL KIT Terumo Medical Corp. CFT Class I 1986-01-13
K854989 CANWEST-PREGBLUE Canwest Medictex, Inc. JHI Class II 1986-01-13
K854837 LEE-BEAD BETA FSH (EIA) Leeco Diagnostics, Inc. CGJ Class I 1986-01-13
K854846 VISION CREATININE Abbott Laboratories CGX Class II 1986-01-13
K854973 V-TREND OC CPK V-Tech, Inc. JJT Class I 1986-01-13

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