meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
59
Latest Decision
1977-01-12

Clearances · page 130 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K760969 PH/BLOOD GAS SYSTEM Instrumentation Laboratory CO CHL Class II 1977-01-12
K760975 WEIL ONCOMETER (IL 186) Instrumentation Laboratory CO JJK Class I 1977-01-12
K761086 REAGENTS Simmler & Son, Inc. JJC Class I 1977-01-12
K761177 SODIUM CITRATE Bio/Data Corp. GJE Class II 1977-01-10
K761337 AQUAMATIC K-MODULE MODEL K-10 Gorman Rupp Industries JRR Class I 1977-01-10
K761346 RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) New England Nuclear CGR Class II 1977-01-07
K760786 ENZYMATIC LIPASE MAX-PACK REAGENT Calbiochem CHI Class I 1977-01-06
K761343 DYNAZYME-II TM LDH-L 340 KIT J.T. Baker Chemical Co. CFJ Class II 1977-01-05
K761344 DYNAZYME-II TM CK-230 KIT J.T. Baker Chemical Co. CGS Class II 1977-01-05
K761345 GLUCO-HEX TM REAGENT KIT J.T. Baker Chemical Co. CFR Class II 1977-01-05
K761305 CENTRIA T3 RIA Union Carbide Corp. CDP Class II 1976-12-30
K761282 DATA-TOPE T4 RIA PROCEDURE Dade, Baxter Travenol Diagnostics, Inc. CDX Class II 1976-12-30
K761267 ANGIOTENSIN I IMMUTOPE KIT Squibb & Sons, Inc. CIB Class II 1976-12-30
K761309 OB-GYN CONTROL SERA (CODE 196300) Amersham Corp. JIX Class II 1976-12-30
K761262 TRIGLYCERIDES (LIPASE) REAGENT SET Worthington Biochemical Corp. CDT Class I 1976-12-29
K760749 SYSTEM 5 - SEMI-AUTOMATED CLIN. ANALY Gilford Instrument Laboratories, Inc. JJC Class I 1976-12-29
K761238 AUTO-INORGANIC PHOSPHORUS REAGENT Harleco CEO Class I 1976-12-29
K761239 AUTO-INORGANIC PHOSPHORUS REAGENT Harleco CEO Class I 1976-12-29
K761263 CHOLESTEROL AUTOMATED REAGENT Worthington Biochemical Corp. CHH Class I 1976-12-29
K761269 GEMENI GPT (ALT) ASSAY Electro-Nucleonics Laboratories, Inc. CKA Class I 1976-12-29
K761261 ENZYMATIC BUN (RATE) REAGENT KIT Beckman Instruments, Inc. CDQ Class II 1976-12-29
K761240 AUTO-ENZYMATIC GLUCOSE Harleco CFR Class II 1976-12-29
K761248 ELECTROPHORESIS ACCESSORY MO. 3526 Gilford Instrument Laboratories, Inc. JJN Class I 1976-12-21
K761197 CHOLESTEROL CALIBRATOR Beckman Instruments, Inc. JIT Class II 1976-12-21
K761218 AUTO TOTAL BILIRUBIN REAGENT Harleco CIG Class II 1976-12-21
K761212 CPK1SOENZYMES DETERMINATION PRO. #715-EP Sigma Chemical Co. JHY Class II 1976-12-21
K760946 B12/FOLATE SING. TUBE DUAL RADIOASSAY KT Schwarz Mann CDD Class II 1976-12-21
K761257 AUTO TOTAL PROTEIN Harleco CEK Class II 1976-12-21
K761217 AUTO TOTAL PROTEIN Harleco CEK Class II 1976-12-21
K761200 ENZYMATIC TRIGLYCERIDES (END POINT) Beckman Instruments, Inc. CDT Class I 1976-12-21
K761214 WELL COUNTERS, LOGIC II (200 SERIES) Abbott Laboratories JJJ Class I 1976-12-16
K761165 MT II - TEST FOR CONTINUOUS FLOW ANAL Technicon Instruments Corp. JJC Class I 1976-12-13
K761181 GLUCOSE OXIDASE REAGENT SYSTEM Nobel Scientific Industries, Inc. CGA Class II 1976-12-13
K761168 MAX L SYSTEM Brinkman Instruments, Inc. DPM Class I 1976-12-10
K760989 URIC ACID REAGENT SET Worthington Biochemical Corp. CDO Class I 1976-12-09
K761152 S-UREA-N, IN VITRO DIAG FOR BUN Advanced Biomedical Methods, Inc. CDL Class II 1976-12-09
K761153 GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE Advanced Biomedical Methods, Inc. CGA Class II 1976-12-09
K760642 ANALYZER, PROGRAMMABLE DISCRETE (PDA) Anatronics Corp. JJE Class I 1976-12-09
K761154 GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ Advanced Biomedical Methods, Inc. CGA Class II 1976-12-09
K760619 RADIO IMMUNO ASSAY KIT/ New England Nuclear CDD Class II 1976-12-06
K761100 MULTI-CELL ULTRAFILTRATION SYSTEM Amicon, Inc. JQQ Class I 1976-12-06
K761063 GAMMACORD II CALCULATOR INTERFACE Miles Laboratories, Inc. JQP Class I 1976-12-02
K761090 DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE Technicon Instruments Corp. JQB Class I 1976-12-02
K761026 AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL Harleco Diagnostics CIX Class II 1976-11-30
K761027 AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN Harleco CIG Class II 1976-11-30
K760769 TEMPERATURE REGULATED FIVE CELL HOLDERS The Perkin-Elmer Corp. JRI Class I 1976-11-30
K761029 AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL Harleco CJY Class II 1976-11-30
K761028 AUTO-ALBUMIN REAG FOR ABBOTT ABA-100 Harleco CIX Class II 1976-11-30
K760711 REAGENT SYSTEM (NO. SC 135) Sigma Chemical Co. JPZ Class I 1976-11-30
K760713 TRIGLYCERIDES TEST Boehringer Mannheim Corp. CDT Class I 1976-11-29
K760622 LANCER AUTOANALYZER MANIFOLD PUMP TUB Sherwood Medical Industries JJC Class I 1976-11-24
K760634 ACA PHOSPHORUS ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. CEO Class I 1976-11-24
K760737 SCATTERED TRANSMISSION ACCESSORY The Perkin-Elmer Corp. JJQ Class I 1976-11-24
K760685 SIGMA PROCED #SC165 Sigma Chemical Co. CJE Class II 1976-11-24
K760572 SERALUTE Miles Laboratories, Inc. CDX Class II 1976-11-23
K760592 MINICON CONCENTRATOR Amicon, Inc. JJH Class I 1976-11-23
K760255 TEST SYSTEM, THYROID STIM. HORMONE ASSAY Corning Medical & Scientific JLW Class II 1976-11-19
K760908 MINIATURE ASCENDING PAPER CHROMATO- Ackerman Nuclear, Inc. DPA Class I 1976-11-19
K760939 CORTISOL REAGENT SYSTEM Beckman Instruments, Inc. CGR Class II 1976-11-16
K761013 SPINETTE CENTRIFUGE Damon Corp. JQC Class I 1976-11-16
K760900 GAMMA SCINTILLATION COUNTER Beckman Instruments, Inc. JJJ Class I 1976-11-16
K760739 ACA DATA MATE ACCESSORY E.I. Dupont DE Nemours & Co., Inc. JQP Class I 1976-11-16
K760990 INORGANIC PHOSPHOROUS REAGENT Worthington Biochemical Corp. CEO Class I 1976-11-16
K760788 PH METER-125 (.01 PH) Corning Medical & Scientific JQY Class I 1976-11-16
K760789 PH METER-130 (.001 PH) Corning Medical & Scientific JQY Class I 1976-11-16
K760336 BIOCEPT-G Wampole Laboratories JHI Class II 1976-11-12
K760920 CAT-A-KIT The Upjohn Co. CHT Class I 1976-11-09
K760885 KETOTROL-E Sigma Chemical Co. JJX Class I 1976-11-05
K760818 TRIS BICARBONATE DILUENT Hyland Therapeutic Div., Travenol Laboratories JJY Class I 1976-11-05
K760415 ENZYMATIC AMYLASE REAGENT KIT Beckman Instruments, Inc. CIJ Class II 1976-11-05
K760414 ENZYMATIC BUN REAGENT KIT Beckman Instruments, Inc. CDQ Class II 1976-11-05
K760409 SODIUM NITRITE J.T. Baker Chemical Co. CIG Class II 1976-11-02
K760408 POTASSIUM SODIUM TARTRATE J.T. Baker Chemical Co. CIG Class II 1976-11-02
K760863 PRODUCT #K3002 KETOTROL-N(URINE CONTROL) Sigma Chemical Co. JJW Class I 1976-11-02
K760862 PROCEDURE NO. 710-EP FOR ALK.PHOS. Sigma Chemical Co. CIN Class II 1976-11-02
K760871 LANCER MB/CPK ISOENZYME KIT Sherwood Medical Industries JHY Class II 1976-11-02
K760424 LIQUID SCINTILLATION COUNTER Beckman Instruments, Inc. JJJ Class I 1976-11-02
K760412 LDH SUBSTRATE J.T. Baker Chemical Co. CFJ Class II 1976-11-02
K760546 REAGENT KIT, ENZYMATIC CO2 Beckman Instruments, Inc. KHS Class II 1976-11-01
K760470 COUNTER, RACK GAMMA (#1270) Lkb Instruments, Inc. JJJ Class I 1976-11-01
K760366 REAGENT, Y-GT MAX-PACK Calbiochem JPZ Class I 1976-11-01
K760801 TSH RIA KIT Diagnostic Products Corp. JLW Class II 1976-11-01
K760373 RADIOASSAY KIT, IM.72 FSH Amersham Corp. CGJ Class I 1976-11-01
K760397 REAGENT, AMP BUFFER DIAGNOSTIC J.T. Baker Chemical Co. CJE Class II 1976-11-01
K760395 PHOTOMETER, SEROMETER (MODEL 380) Mallinckrodt Critical Care JJQ Class I 1976-11-01
K760468 TEST, REFORMULATED HYCEL HMA CALCIUM Hycel, Inc. CIC Class II 1976-11-01
K760553 PRINTER Turner Assoc. JJQ Class I 1976-11-01
K760476 REAGENT, LACTATE DEHYDROGENASE Simmler & Son, Inc. CFJ Class II 1976-11-01
K760430 BUN-REATIVE Boehringer Mannheim Corp. CDS Class II 1976-11-01
K760394 REAGENT, CHLORIDOMETER ACID Bulcher Instruments JFS Class II 1976-11-01
K760748 REAGENTS FOR BLOOD GAS INSTRUMENTATION Alko Scientific Co. CHL Class II 1976-11-01
K760828 BLASTOMYCES YEAST ANTIGEN I M, Inc. JJJ Class I 1976-11-01
K760543 BROMCRESOL GREEN Fisher Scientific Co., LLC CIX Class II 1976-11-01
K760478 REAGENT, BUN (UREA NITROGEN) DETERM. Simmler & Son, Inc. CDW Class II 1976-10-29
K760406 CAFFEINE DILUENT J.T. Baker Chemical Co. CIG Class II 1976-10-29
K760474 REAGENT, ALKALINE PHOSPHATASE DETERM. Simmler & Son, Inc. CJE Class II 1976-10-29
K760467 ROTATOR, FIXED SPEED Lederle Laboratories JQC Class I 1976-10-29
K760398 REAGENT, MAGNESIUM CHLORIDE J.T. Baker Chemical Co. CJE Class II 1976-10-29
K760591 SIGMA PROCEDURE NO. 745 - EP.REAGENT SY Sigma Chemical Co. JHX Class II 1976-10-29
K760449 LIPID CONTROL Sigma Chemical Co. JJX Class I 1976-10-29

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