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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
52
Latest Decision
1978-04-06

Clearances · page 125 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K780331 CHOLESTEROL RAPID SLAT KIT HDL Pierce Chemical Co. CHH Class I 1978-04-06
K780251 NEPHELOMETER Kallestad Laboratories, Inc. JQX Class I 1978-04-06
K780295 CALIBRATORS, CARBON DIOXIDE E.I. Dupont DE Nemours & Co., Inc. JIT Class II 1978-04-05
K780311 DIAGNOSTIC KIT, CPK Sclavo, Inc. CGS Class II 1978-04-05
K780129 ATOMIZER, FURNACE, GRAPHITE The Perkin-Elmer Corp. JXR Class I 1978-04-05
K780262 DIRECT UREA NITROGEN TEST Hycel, Inc. CDW Class II 1978-04-05
K780321 PREGNANCY TEST KIT, OVER-THE-COUNTER Intl. Diagnostic, Inc. LCX Class II 1978-04-04
K780423 STIKSEP-T4 RIA KIT Nuclear Diagnostics, Inc. CDX Class II 1978-03-30
K780303 AUTO ISO-FILTER COLLECTION TUBE CAP Bd Becton Dickinson Vacutainer Systems Preanalytic GJE Class II 1978-03-30
K780428 ROCHE TSH RIA Hoffmann-La Roche, Inc. JLW Class II 1978-03-30
K780256 HDL CHOLESTEROL METHOD Helena Laboratories JHO Class I 1978-03-28
K780253 REAGENT SYSTEM, ARIA II T3 UPTAKE Bd Becton Dickinson Vacutainer Systems Preanalytic KHQ Class II 1978-03-28
K780242 SPECTROPHOTOMETER, FLUORESCENCE M.650-10 The Perkin-Elmer Corp. KHO Class I 1978-03-27
K780383 COUNTER, RADIOASSAY, AUTO., MICROMEDIC Micromedic Systems JJJ Class I 1978-03-22
K780388 ANALYZER, 100, BICHROMATIC, ABBOTT Syva Co. JJE Class I 1978-03-22
K780362 SPECTROFLUOROMETER SF-330 Varian Assoc., Inc. KHO Class I 1978-03-22
K780361 T3 UPTAKE TEST Monobind KHQ Class II 1978-03-22
K780390 SPECTROPHOTOMETER, ABSORPTION, ATOMIC Varian Assoc., Inc. JXR Class I 1978-03-22
K780121 REAGENTS, MANUEAL, ASSAY, THYROXINE Syva Co. CDX Class II 1978-03-17
K780099 ULTRAZYME PLUS GT Harleco JPZ Class I 1978-03-09
K780141 ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI. Harleco CIJ Class II 1978-03-09
K780172 TRIGLYCERIDE INSTRUMENT APPLICATION Harleco CDT Class I 1978-03-09
K780083 ANALYZER, SELECTIVE, ELECTRONIC Johns Scientific, Inc. JJE Class I 1978-03-09
K780100 ULTRAZYME PLUS CK-1 Harleco CGS Class II 1978-03-09
K780096 LDH ISOENZYME CONTROL SERUM Worthington Biochemical Corp. JJY Class I 1978-03-03
K780148 RIA FOR FOLATES & VIT. B12, COMBO KIT Ria Products, Inc. CGN Class II 1978-03-03
K780219 ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY Syva Co. CDX Class II 1978-03-03
K780208 ASPIRATOR, MANUEL Dade, Baxter Travenol Diagnostics, Inc. JQW Class I 1978-03-03
K780110 CSF TOTAL PROTEIN TEST SET #0340 Stanbio Laboratory JGQ Class II 1978-03-03
K780204 CHEMISTRY CONTROL & REFERENCE SERUMS Hyland Therapeutic Div., Travenol Laboratories JJT Class I 1978-03-03
K772308 AUTOZYME GLUCOSE OXIDASE (TRINDER) J.T. Baker Chemical Co. CGA Class II 1978-03-03
K780292 TRIA-PEG RIA DIAG. KIT Nuclear Diagnostics, Inc. CDP Class II 1978-03-02
K772153 FLAME PHOTOMETER STANDARD Alko Scientific Co. JIT Class II 1978-02-28
K780240 PREDICTOR Organon, Inc. LCX Class II 1978-02-27
K780147 ISOENZYME SERUM CONTROL Corning Medical & Scientific JJT Class I 1978-02-23
K780146 T3 STI KIT Polysciences, Inc. KHQ Class II 1978-02-23
K780179 LIQUID SCINTILLATION COUNTER Roche Medical Electronics, Inc. JJJ Class I 1978-02-23
K780156 SPECTROPHOTOMETER, MODEL 380 Turner Assoc. JJQ Class I 1978-02-23
K780069 BUN REAGNET SET Medical Analysis Systems, Inc. CDQ Class II 1978-02-14
K780072 GLUCOSE REAGENT SET Medical Analysis Systems, Inc. CFR Class II 1978-02-14
K780071 GAMA-GPT REAGENT SET Medical Analysis Systems, Inc. JQB Class I 1978-02-14
K780101 ULTRAZYME PLUS LDH Harleco CFJ Class II 1978-02-14
K780070 CPK REAGENT SET Medical Analysis Systems, Inc. CGS Class II 1978-02-13
K780050 THYROXINE STDS. IN HUMAN SERUM Pcl-Ria, Inc. CDX Class II 1978-02-13
K780104 ULTRAZYME PLUS HBD Harleco JMK Class I 1978-02-13
K780094 IRON BINDING CAPACITY CHEMISTRY Harleco JMO Class I 1978-02-13
K780093 GLUCOSE REAGENT FOR GLUCOSE ANALYZER Harleco CGA Class II 1978-02-13
K780073 HBDH REAGENT SET Medical Analysis Systems, Inc. JMK Class I 1978-02-13
K780102 ULTRAZYME PLUS GPT Harleco CKA Class I 1978-02-13
K780103 ULTRAZYME PLUS GOT Harleco CIT Class II 1978-02-13
K780059 RABBIT ANTIBODY/THYROID STIMUL. HORMONE Pcl-Ria, Inc. JLW Class II 1978-02-13
K780095 ULTRAZYME PLUS ALP Harleco CJE Class II 1978-02-13
K780068 ALP REAGENT SET Medical Analysis Systems, Inc. CJE Class II 1978-02-07
K780018 THYRO-INDICATOR T-3 125I Clinical Immuno-Diagnostics CDP Class II 1978-02-07
K780015 THYROID STIMULATING HORMONE Pcl-Ria, Inc. JLW Class II 1978-02-07
K780092 ULTRACHEM ALBUMIN Harleco CIX Class II 1978-02-07
K780080 LACTATE DEHYDROGENASE COLORIMETRIC SUB. Corning Medical & Scientific CFE Class II 1978-02-07
K780122 HTSH RIA Abbott Laboratories KHO Class I 1978-02-03
K780016 HUMAN FOLLICLE STIMULATING HORMONE Pcl-Ria, Inc. CGI Class I 1978-02-03
K780042 HYDORRYBUTYRATE DEHYDROGENASE Beckman Instruments, Inc. JMK Class I 1978-02-01
K780065 ULTRACHEM E-GLU, MANUAL DETERM. Harleco CFR Class II 1978-02-01
K780041 LACTATE DEHYDROGENASE Beckman Instruments, Inc. CFJ Class II 1978-02-01
K780040 ALANINE TRANSAMINASE Beckman Instruments, Inc. CKA Class I 1978-01-31
K780039 ASPARTATE TRANSAMINASE Beckman Instruments, Inc. CIT Class II 1978-01-31
K772344 DATA ACQUISITION & COLLATING SYS. Gilford Instrument Laboratories, Inc. JJE Class I 1978-01-31
K772352 STAC SYSTEM - ADDITIONAL ANALYTES Technicon Instruments Corp. CGS Class II 1978-01-31
K772361 LASER IMMUNONEPHELOMETRIC ANALYZER G.D. Searle and Co. JQX Class I 1978-01-30
K772426 17-HYDROXY TEST Hycel, Inc. CDB Class I 1978-01-30
K780013 SERUM GLUTAMIC OXALOACETIC TRANSAMINASE Macomb Chemical Co. CIT Class II 1978-01-30
K780112 SPECTROPHOTOMETER, MODEL 5000 The Perkin-Elmer Corp. JXR Class I 1978-01-30
K772099 PRINTER Miles Laboratories, Inc. JJJ Class I 1978-01-26
K772356 LDH ISOENZYME COLUMN REAGENT SET Worthington Biochemical Corp. CEX Class II 1978-01-24
K780031 FLUORESCENCE DETECTOR MODEL 420 Waters Assoc., Inc. KHO Class I 1978-01-20
K771947 INSULIN RIA MODULE Inter Science Institute CFP Class I 1978-01-20
K771948 GLUCAGON RIA MODULE Inter Science Institute JME Class I 1978-01-20
K771953 GASTRIN RIA MODULE Inter Science Institute CGC Class I 1978-01-20
K772325 DENSITOMETER 18, COMPUTING, AUTO. Gelman Instrument Co. JQT Class I 1978-01-12
K772337 URINARY 17-KETOSTERIOD/17 Eppendorf-Brinkmann, Inc. CDG Class I 1978-01-12
K772319 ANALYZER, CLINICAL, SYSTEM 3 Gilford Instrument Laboratories, Inc. JJE Class I 1978-01-12
K772330 T4 RIA KIT Bd Becton Dickinson Vacutainer Systems Preanalytic CDX Class II 1978-01-12
K772191 TESTOSTERONE RIA KIT (125I) Diagnostic Products Corp. CDZ Class I 1978-01-12
K772192 NEONATAL TSH RIA KIT (125I) Diagnostic Products Corp. JLW Class II 1978-01-12
K772311 WISP MODEL 710 Waters Assoc., Inc. CHH Class I 1978-01-12
K772281 RSL INSULIN KIT Radioassay Systems Laboratories, Inc. CFP Class I 1978-01-06
K772194 IMMO PHASE FT4 ASSAY Corning Medical & Scientific CEC Class II 1978-01-06
K772285 ACA LIPASE VERIFIERS E.I. Dupont DE Nemours & Co., Inc. JJX Class I 1978-01-06
K771415 RIA FOR SERUM THYROXINE Clinical Immuno-Diagnostics CDX Class II 1978-01-05
K772359 PREGNANCY TEST KIT, ANSWER Diagnostic Testing, Inc. LCX Class II 1978-01-05
K772258 CLINICARD CK-II Harleco CGS Class II 1978-01-05
K772323 RIANEN ESTRIOL RIA KIT New England Nuclear CGI Class I 1978-01-05
K772364 AUTO. SAMPLING SYSTEM Hewlett-Packard Co. KIE Class I 1978-01-05
K772307 PCO 2 ELECTROLYTE Fisher Scientific Co., LLC CHL Class II 1977-12-22
K772170 EMIT CENTRIFICHEM THYROXINE ASSAY Syva Co. CDX Class II 1977-12-22
K772249 COMPLEMENT C3 NEPHELOMETRIC ASSAY Kallestad Laboratories, Inc. CEW Class II 1977-12-22
K772177 TRI-TAB-RIA Nuclear Medical Laboratories, Inc. CDP Class II 1977-12-22
K772215 UNCONJUGATED ESTRIOL RIA KIT Amersham Corp. CGI Class I 1977-12-22
K771894 LDH ISOENZYME CONTROL Bio-Reagents & Diagnostics, Inc. CEX Class II 1977-12-22
K772257 ALKALINE PHOSPHATASE TEST SET Stanbio Laboratory CIO Class II 1977-12-22
K771854 SPINSEP-T3 Nuclear Diagnostics, Inc. KHQ Class II 1977-12-22
K771609 PEDIATRIC THYROXINE TEST SYS. T4 Corning Medical & Scientific CDX Class II 1977-12-20

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