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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
54
Latest Decision
1977-05-03

Clearances · page 129 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K770451 ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL Icn Pharmaceuticals, Inc. CIX Class II 1977-05-03
K770455 GLUCOSE PROCEDURE, TEKPOINT DIRECT Icn Pharmaceuticals, Inc. CGE Class II 1977-05-03
K770452 PROTEIN PROCEDURE, TEKPOINT TOTAL Icn Pharmaceuticals, Inc. CEK Class II 1977-05-03
K770449 CALCIUM PROCEDURE, TEKPOINT DIRECT Icn Pharmaceuticals, Inc. CIC Class II 1977-05-03
K770454 CREATININE PROCEDURE, TEKPOINT Icn Pharmaceuticals, Inc. CGX Class II 1977-05-03
K770679 CHEMISTRY, COULTER Coulter Electronics, Inc. JJE Class I 1977-05-03
K770459 URIC ACID PROCEDURE, TEKPOINT DIRECT Icn Pharmaceuticals, Inc. CDH Class I 1977-04-29
K770726 RIA KIT, T4 CLASP Squibb & Sons, Inc. CDX Class II 1977-04-28
K770474 THYROSCREEN TM T4 DIAGNOSTIC KIT Abbott Laboratories CDX Class II 1977-04-28
K770393 PROPANE, HIGH PURITY, INSTRUMENT GRADE Hycel, Inc. JJO Class I 1977-04-26
K770400 REAGENT, AMYLASE LIPASE Bd Becton Dickinson Vacutainer Systems Preanalytic KHM Class II 1977-04-26
K770401 LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE Bd Becton Dickinson Vacutainer Systems Preanalytic JJI Class I 1977-04-26
K770012 Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C Hyland Therapeutic Div., Travenol Laboratories JIX Class II 1977-04-18
K770011 Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B Hyland Therapeutic Div., Travenol Laboratories JIX Class II 1977-04-18
K770010 Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A Hyland Therapeutic Div., Travenol Laboratories JIX Class II 1977-04-18
K770572 DP-5000 DATA REDUCTION SYSTEM Beckman Instruments, Inc. JJJ Class I 1977-04-15
K770494 BLOOD GAS ANALYZER-CALIBRATION GAS Gardner Cryogenics JIX Class II 1977-04-15
K770364 ACA LIPASE ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. CET Class I 1977-04-15
K770347 METER, PH, DIGITAL, MODEL 3560 Beckman Instruments, Inc. JQY Class I 1977-04-15
K770380 CHEMISTRY CONTROL-LOW & HIGH TQC TM Technicon Instruments Corp. JJY Class I 1977-04-15
K770526 DIGITAL SCANNER The Perkin-Elmer Corp. JXR Class I 1977-04-08
K770363 ACA AMMONIA ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. JIF Class I 1977-04-08
K770444 SPECTROPHOTOMETER ANALYSIS SYS., AA-375 Varian Assoc., Inc. JXR Class I 1977-04-08
K770352 METER, IV PH, MODEL EXPANDOMATIC Beckman Instruments, Inc. JQY Class I 1977-04-08
K770443 SPECTROPHOTOMETER ANALYSIS SYS., AA-175 Varian Assoc., Inc. JXR Class I 1977-04-08
K770480 IN VITRO T-3 UPTAKE TEST Clinical Assays, Inc. KHQ Class II 1977-04-06
K770604 RIA-DAC TM HTSH KIH Mallinckrodt Critical Care JLW Class II 1977-04-06
K770398 MINICON Amicon, Inc. JJH Class I 1977-04-06
K770318 REAGENT GOT, ENZYME Icn Pharmaceuticals, Inc. CIT Class II 1977-04-05
K770201 T3 RIA (PEG) DIAGNOSTIC KIT Abbott Laboratories CDP Class II 1977-04-05
K770306 ANALYZER, 751 KINETIC/ENDPOINT Sclavo, Inc. JJQ Class I 1977-04-05
K770310 CHEMISTRY CONTROL, NORMAL Icn Pharmaceuticals, Inc. JJY Class I 1977-04-05
K770307 MICRO/PETTOR, SMI Lederle Laboratories JQW Class I 1977-04-05
K770351 METER, IV PH, MODEL ZEROMATIC Beckman Instruments, Inc. JQY Class I 1977-04-05
K770313 REAGENT LDH-L, ENZYME Icn Pharmaceuticals, Inc. CFJ Class II 1977-04-05
K770315 BUN, ENZYMATIC Icn Pharmaceuticals, Inc. CDQ Class II 1977-04-05
K770319 REAGENT CPK, ENZYME Icn Pharmaceuticals, Inc. CGS Class II 1977-04-05
K770312 CHEMISTRY CONTROL, ABNORMAL Icn Pharmaceuticals, Inc. JJY Class I 1977-04-05
K770314 REAGENT GPT, ENZYME Icn Pharmaceuticals, Inc. CKA Class I 1977-03-30
K770317 GLUCOSE TRINDER, ENZYMATIC Icn Pharmaceuticals, Inc. CGA Class II 1977-03-30
K770316 ALKALINE PHOSPHATASE ENZYMATIC Icn Pharmaceuticals, Inc. CJE Class II 1977-03-30
K770311 GLUCOSE REAGENT, ENZYMATIC Icn Pharmaceuticals, Inc. CFR Class II 1977-03-30
K770107 SERI-SEP Torval Corp. JKA Class II 1977-03-22
K761306 CLINILAB AUTOMATED URINALYSIS SYSTEM Miles Laboratories, Inc. KQO Class I 1977-03-21
K761310 MEGA-DIASTIX Miles Laboratories, Inc. JIL Class II 1977-03-21
K761321 VITAMIN B12 RADIOASSAY Kallestad Laboratories, Inc. CDD Class II 1977-03-21
K761329 MT II SYSTEM - SERUM ALBUMIN Technicon Instruments Corp. CIX Class II 1977-03-21
K761272 CENTRIA T4 RIA Clinical Diagnostics, Inc. CDX Class II 1977-03-16
K770271 CHEMSTRIP G Boehringer Mannheim Corp. JIL Class II 1977-03-16
K770278 SPECTROPHOTOMETERS, INFRARED MODELS X99 The Perkin-Elmer Corp. JJQ Class I 1977-03-10
K770288 SPECTROPHOTOMETER, MODEL 597 IR The Perkin-Elmer Corp. JJQ Class I 1977-03-10
K770355 PIPETTOR W/DETIPPER Sherwood Medical Industries JQW Class I 1977-03-08
K770277 CHOLESTEROL STANDARDS Worthington Biochemical Corp. JIT Class II 1977-03-01
K770273 TEST, AMMONIA, BMC REAGENTSET Boehringer Mannheim Corp. JIF Class I 1977-03-01
K770229 AUTO-ENZYMATIC GLUCOSE Harleco CFR Class II 1977-03-01
K770193 PIPETTOR, 400, CENTRIFICHEM SYSTEM Universal Instruments Corp. JQW Class I 1977-03-01
K770272 URIC ACID TEST, BMC AUTOFLO Boehringer Mannheim Corp. KNK Class I 1977-03-01
K770208 MOTORIZED OPERATOR FOR PIPETTING DEV. Kensington Scientific JQW Class I 1977-02-28
K770255 LC-65T DETECTOR AND OVEN The Perkin-Elmer Corp. KZR Class I 1977-02-25
K770265 CHOLESTEROL TEST Sclavo, Inc. CHH Class I 1977-02-25
K761290 COMPU-PET 300 Nuclear Medical Laboratories, Inc. JQW Class I 1977-02-24
K761315 ALKALINE PHOSPHATASE (ALP)/PNPP Princeton Biomedix CJE Class II 1977-02-24
K761283 TRI-CON TRIGLYCERIDGE REAGENTS Dade, Baxter Travenol Diagnostics, Inc. JGY Class I 1977-02-24
K770254 CHROMATOGRAPH, SERIES 3, LIQUID The Perkin-Elmer Corp. KZR Class I 1977-02-24
K770200 GO/HPO-GLUCOSE REAGENT (TRINDER) Beckman Instruments, Inc. CGA Class II 1977-02-23
K770262 GLUCOSE (HEXOKINASE) DELTA TEST ASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic CFR Class II 1977-02-23
K770267 LDH-L TEST Sclavo, Inc. CFJ Class II 1977-02-23
K770242 REAGENT SYSTEM American Monitor Corp. CGX Class II 1977-02-22
K770025 GAS CHROMOTOGRAPHS, SIGMA 1,2,3,4,&10 The Perkin-Elmer Corp. KZQ Class I 1977-02-16
K770088 GAMMA 4000 SCINTILLATION COUNTER Beckman Instruments, Inc. JJJ Class I 1977-02-14
K761271 URIN. L7-OH CORTICOSTEROID T(NON HYDRO) Eppendorf-Brinkmann, Inc. CDB Class I 1977-02-14
K770241 NEONATAL T4 RIA KIT Diagnostic Products Corp. CDX Class II 1977-02-14
K761280 AUTO CREATININE REAGENT (GILFORD 3400-E) Harleco CGX Class II 1977-02-14
K770210 ANALYTIX AUTO SAMPLE PREP. STA. 1600 G.D. Searle and Co. JQW Class I 1977-02-14
K761148 REFLOMAT/REFLOTEST SYSTEM Boehringer Mannheim Corp. CGA Class II 1977-02-11
K770142 SMA REFERENCE SERUM 3 Technicon Instruments Corp. JIX Class II 1977-02-11
K761279 AUTO CREATININE REAGENT (ABBOTT SYSTEM) Harleco CGX Class II 1977-02-11
K761281 DATA-TOPE T3 UPTAKE PROCEDURE Dade, Baxter Travenol Diagnostics, Inc. KHQ Class II 1977-02-09
K770033 SPAC TM T3 UPTAKE KIT Mallinckrodt Critical Care KHQ Class II 1977-02-07
K770156 SPAC TM T4 RIA KIT Mallinckrodt Critical Care CDX Class II 1977-02-07
K761316 ABSORPTION SPECTROPHOTOMETERS The Perkin-Elmer Corp. JXR Class I 1977-02-07
K761351 L080 SERIES LIQUID CHROMATOGRAPH Hewlett-Packard Co. KIE Class I 1977-02-02
K761219 SERIES II LIQUID CHROMATOGRAPH The Perkin-Elmer Corp. KIE Class I 1977-02-01
K761342 SMA MICROLYZER Technicon Instruments Corp. JJC Class I 1977-02-01
K770126 CENTRIFICHEM CHOLES. CALIB. STD. SET Union Carbide Corp. JIT Class II 1977-01-31
K770155 ALKALINE PHOSPHATASE ISOYZME REAGENT SET Gelman Instrument Co. CJO Class II 1977-01-31
K770121 MANUEL BILIRUBIN REAGENT SET Harleco CIG Class II 1977-01-31
K770165 MICRO-MIX PIPETTE SHAKER Maddak, Inc. JRQ Class I 1977-01-31
K770127 CENTRIFICHEM 200MG/DL CHOL. CAL. STD. Union Carbide Corp. JIT Class II 1977-01-31
K770072 BIO TROL-T TRIOLEIN SOLUTIONS Boehringer Mannheim Corp. JIS Class II 1977-01-26
K770026 FLOUROMETER/DENSITOMETER MODEL 720 Corning Medical & Scientific JQT Class I 1977-01-26
K761136 GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT Beckman Instruments, Inc. CHH Class I 1977-01-26
K770049 LDH ISOTROL T Sigma Chemical Co. JJT Class I 1977-01-26
K761320 GLUCOSE KIT Environmental Chemical Specialties CFR Class II 1977-01-25
K761061 BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 Beckman Instruments, Inc. CDS Class II 1977-01-25
K770013 PIPETTING DEVICES Kensington Scientific JQW Class I 1977-01-25
K761089 GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT Beckman Instruments, Inc. CHH Class I 1977-01-25
K761060 GLUCOSE ANALYZER 2 Beckman Instruments, Inc. CGA Class II 1977-01-25
K770070 ENIT ABA THYROXINE ASSAY Syva Co. KLI Class II 1977-01-21
K761226 GP3%SP-2100DOHON100/120 MESH SUPELCOPORT Supelco, Inc. JSQ Class I 1977-01-14

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