meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
55
Latest Decision
1983-08-12

Clearances · page 103 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K832070 AMRESCO NA/K REAGENT SET American Research Products Co. JGS Class II 1983-08-12
K832198 HC40/HC75 PREPACKED COLUMS Hamilton Co. DJY Class I 1983-08-12
K832046 SERALYZER MULTICOMPONENT CALIBRATORS Miles Laboratories, Inc. JIX Class II 1983-08-11
K831775 UCG-BETA SLIDE MONOCLONAL Armkel, LLC JHJ Class II 1983-08-11
K832094 BILIRUBIN CALIBRATORS & CONTROL Gilford Diagnostics JIT Class II 1983-08-11
K832071 TOTAL CO2 REAGENT SET American Research Products Co. CIE Class II 1983-08-11
K832004 WAKO CPK TEST Wako Chemicals USA, Inc. JHY Class II 1983-08-11
K831613 MAGIC TM 125I T3 UPTAKE RADIOASSAY Corning Medical & Scientific KHQ Class II 1983-08-11
K832003 AQUEOUS BLOOD GAS CONTROL LEVEL I,II & American Dade JJS Class I 1983-08-10
K831389 STAT-TRAK LIQUID ELECTROLYTE CONTROL United Diagnostics, Inc. JJR Class I 1983-08-10
K831983 DATA-ZYME URIC ACID PROCEDURE Data Medical Associates, Inc. KNK Class I 1983-08-08
K831994 BIOCHECK POSITIVE URINE CONTROL Helena Laboratories JJW Class I 1983-08-08
K832002 NML-5010/5020 MULTI-DETECTOR SYSTEM Nuclear Medical Laboratories, Inc. JJJ Class I 1983-08-08
K831989 VISIDEX II REAGENT STRIPS Miles Laboratories, Inc. CGA Class II 1983-08-08
K831947 LKB 2160 MIDISPIN CENTRIFUGE Lkb Instruments, Inc. JQC Class I 1983-07-29
K831942 LKB 2164 MACRO-SPIN R CENTRIFUGE Lkb Instruments, Inc. JQC Class I 1983-07-29
K831948 LKB 2161 MIDISPIN R CENTRIFUGE Lkb Instruments, Inc. JQC Class I 1983-07-29
K831855 HATCH KIT Radioassay Systems Laboratories, Inc. CKG Class II 1983-07-28
K831379 MODEL 947 VIDEO BLOOD GAS SYS Avl Scientific Corp. CHL Class II 1983-07-28
K831249 PRO QUANTUM Abbott Laboratories JQW Class I 1983-07-28
K831623 DIA STRIPS SYSTEM California Immuno Diagnostic, Inc. CDM Class I 1983-07-28
K831866 MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC Varian Assoc., Inc. JJQ Class I 1983-07-28
K831863 CHOLESTEROL-ENZYMATIC REAGENT SET Stanbio Laboratory CHH Class I 1983-07-22
K831858 TRIGLYCERIDES REAGENT SET Stanbio Laboratory CDT Class I 1983-07-22
K831864 URIC-ACID TEST ENZYMATIC COLORIMETRIC Stanbio Laboratory KNK Class I 1983-07-22
K831700 MULTICHEM ENZYMATIC CHOLESTEROL SYS Simmler, Inc. CHH Class I 1983-07-19
K831694 RENAK Hoffmann-La Roche, Inc. CIB Class II 1983-07-19
K831523 BETA SCAN NORMAL CONTROL SOLUTION Orange Medical Instruments, Inc. JJX Class I 1983-07-19
K832048 ASTRA SYSTEMS ENZYME MODULE LD-P Beckman Instruments, Inc. CFJ Class II 1983-07-19
K831634 GLUCOSE REAGENT B6360-11 American Scientific Products CGA Class II 1983-07-19
K831604 HCG ACCU-STICK Btc Diagnostics, Inc. JHI Class II 1983-07-19
K831300 MSI-NAK-50 TEST KIT Medical Specialties, Inc. JGM Class II 1983-07-18
K831719 MONOJET SPS BLOOD COLLECTION TUBE Sherwood Medical Co. JKA Class II 1983-07-18
K832028 CERTAIN HB CO-OXIMETER CONTROL Corning Medical & Scientific JJS Class I 1983-07-18
K831742 QUANTIMUNE HFSH RIA HUMAN FOLLICLE- Bio-Rad CGJ Class I 1983-07-18
K831527 SPINAL FLUID TOTAL PROTEIN CONTROL Quantimetrix Corp. JJX Class I 1983-07-18
K831844 DIRECT BILIRUBIN REAGENT Gilford Diagnostics CIG Class II 1983-07-18
K831843 GILCHEM TOTAL BILIRUBIN REAGENT Gilford Diagnostics CIG Class II 1983-07-18
K831826 ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY Damon Corp. CKG Class II 1983-07-18
K832036 QEA SODIUM/POTASSIUM ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic CEM Class II 1983-07-18
K831687 WAKO CHOLESTEROL CII Wako Chemicals USA, Inc. CHH Class I 1983-07-18
K831639 WAKO R-GTP C-TEST Wako Chemicals USA, Inc. JPZ Class I 1983-07-18
K831561 AMYLAST-D TEST Sclavo, Inc. JFJ Class II 1983-07-07
K831626 UREA NITROGEN-BUN-REAGENTS B6370-11A American Scientific Products CDQ Class II 1983-07-07
K831263 ELECTROPHORESIS CONTROLS-3 IN 1 Corning Medical & Scientific JJY Class I 1983-07-07
K831625 UREA NITROGEN-BUN-REAGENTS B6360-12 American Scientific Products CDQ Class II 1983-07-07
K831624 GLUCOSE REAGENT KITS-B6370-10A American Scientific Products CGA Class II 1983-07-06
K831560 GLUCOSE HEXOKINASE DIAG. KIT Sclavo, Inc. CFR Class II 1983-07-06
K831411 GLUCOSE OXIDASE/PEROXIDASE TEST King Diagnostics, Inc. CGA Class II 1983-07-06
K831627 CREATININE REAGENTS B6360-10 American Scientific Products CGX Class II 1983-07-06
K831628 CREATININE REAGENTS B6370-13 American Scientific Products CGX Class II 1983-07-06
K831535 E.P.T. PLUS TM Warner-Lambert Co. JHJ Class II 1983-06-30
K831295 AMYLASE REAGENT #88129 Hi Chem, Inc. KHM Class II 1983-06-30
K831213 SPECIFIC GRAVITY INSTRUMENT Iris JRE Class I 1983-06-30
K831533 MAGIC T4 125I RADIOIMMUNOASSAY Corning Medical & Scientific CDX Class II 1983-06-30
K831434 ISO-SEP SYSTEM Berwick Medical Products, Inc. CDP Class II 1983-06-30
K831569 REAGENT CUPS American Scientific Products JJG Class I 1983-06-30
K831571 ROTOR American Scientific Products JJG Class I 1983-06-30
K831468 B HCG-CHECK Diagnostic Technology, Inc. JHJ Class II 1983-06-22
K831075 BLOOD GAS & FLAME PHOTOMETER INSTRU- United Diagnostics, Inc. CGC Class I 1983-06-22
K831383 EVENT-TEST SLIDE Icl Scientific JHJ Class II 1983-06-22
K831466 HCG-CHECK Diagnostic Technology, Inc. JHJ Class II 1983-06-22
K831480 PARAMAX ALKALINE PHOSPHATASE REAGENT- American Dade CJE Class II 1983-06-22
K831498 URI-TEST 3, INLAB REAGENT STRIPS-URINAL Laprol Scientific, Inc. JIL Class II 1983-06-22
K831518 AUTO CAROUSE/WASH SOLUTION CONCENTRATE Syva Co. JJE Class I 1983-06-22
K831537 PARAMAX CREATINE KINASE REAGENT American Dade CGS Class II 1983-06-22
K831470 PTH MR Ramco Laboratories, Inc. CEW Class II 1983-06-22
K831499 GLUCOSE 3, INLAB REAGENT STRIPS-URINALY Laprol Scientific, Inc. JIN Class I 1983-06-17
K831536 PARAMAX AMALINE REAGENT American Dade JFJ Class II 1983-06-17
K830220 YELLOW IRIS TM Intl. Remote Imaging Systems KQO Class I 1983-06-17
K831477 DEMAND ANALYZER SYSTEM Worthington Diagnostic Systems JJE Class I 1983-06-17
K831025 ELECTROLYLE CARBON DIOXIDE ELECTRODES Fisher Scientific Co., LLC CHL Class II 1983-06-16
K831018 CALIBRATING SOLUTION FOR ABL-1 & 2 Fisher Scientific Co., LLC CHL Class II 1983-06-16
K831414 COLORIMETRIC BUN Bio-Analytics Laboratories, Inc. CDL Class II 1983-06-16
K831024 ELECTROLYTE PO2 FOR OXYGEN ELECTRODES Fisher Scientific Co., LLC CHL Class II 1983-06-16
K831585 ALBUMIN REAGENT (BCG Reagents Applications, Inc. CIX Class II 1983-06-16
K831415 LACTIC DEHYDROGENASE REAGENT SET Sterling Biochemical, Inc. CFJ Class II 1983-06-16
K831289 PREFILLED IEC COLUMNS Berwick Medical Products, Inc. DJY Class I 1983-06-16
K831419 RAICHEM LDH-P REAGENT W/SEPARATE START- Reagents Applications, Inc. CFJ Class II 1983-06-16
K831021 CALIBRATING SOLUTION FOR ABL-1 & 2 Fisher Scientific Co., LLC CHL Class II 1983-06-16
K831069 DAC-CEL PTH KIT RD51 Wellcome Diagnostics CEW Class II 1983-06-16
K831019 PH 6.838 REF. BUFFER Fisher Scientific Co., LLC CHL Class II 1983-06-16
K831023 REFERENCE BUFFER PH 7.382 Fisher Scientific Co., LLC CHL Class II 1983-06-15
K830824 URINE SCREENING KIT Syn-Kit, Inc. CEN Class I 1983-06-12
K831264 BHCG RIA KIT Micromedic Systems JHI Class II 1983-06-08
K831339 NEO-PREGNOSTICON DUOCLON TUBE TEST Organon, Inc. JHJ Class II 1983-06-08
K831013 DIAGNOSTICS PO 2 ELECTROLYTE Fisher Scientific Co., LLC CHL Class II 1983-06-08
K831353 ASTRA SYSTEMS ENZYME MODULE Beckman Instruments, Inc. CFJ Class II 1983-06-08
K831398 LINEAR ENZMATIC URIC ACID SYSTEM Simmler, Inc. KNK Class I 1983-06-08
K831302 PBI BHCG RIA KIT Pacific Biotech, Inc. JHI Class II 1983-06-08
K831345 RIANEN PROLACTIN 125I KIT New England Nuclear CFT Class I 1983-06-08
K830472 LIPOSOL Quest Medical, Inc. JKA Class II 1983-06-08
K831012 DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON Fisher Scientific Co., LLC CHL Class II 1983-06-08
K831360 DATA-ZYME ALKALINE PHOSPHATASE PROCED Data Medical Associates, Inc. CJE Class II 1983-06-08
K831223 BETA-QUIK-15 RIA KIT Pacific Biotech, Inc. JHI Class II 1983-06-02
K831366 TESTCORP PREG Catheter Technology Corp. JHJ Class II 1983-06-02
K830997 ARIA II I-HCG Bd Becton Dickinson Vacutainer Systems Preanalytic JHI Class II 1983-06-02
K831109 DUOCLON SLIDE TEST Organon, Inc. JHI Class II 1983-06-02
K831273 QST TM SAMPLE PROCESSOR Syva Co. JQW Class I 1983-06-02
K831227 COMPUR EASY TOUCH CHEMISTRY ANALYZER- Worthington Diagnostic Systems JJF Class I 1983-06-02

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