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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
67
Latest Decision
1981-10-19

Clearances · page 111 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K812759 NML CK-MB RIA Nuclear Medical Laboratories, Inc. JHX Class II 1981-10-19
K812777 DIRECT IRON REAGENT SET The Dow Chemical Co. JIY Class I 1981-10-19
K812650 BECKMAN ICS NORMAL CONTROL SERA Beckman Instruments, Inc. JJY Class I 1981-10-19
K812649 BECKMAN ICS CALIBRATOR Beckman Instruments, Inc. JIX Class II 1981-10-19
K812754 BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN Beckman Instruments, Inc. CIG Class II 1981-10-19
K812461 TANDEM QUALITATIVE HCG KIT Hybritech, Inc. JHI Class II 1981-10-13
K812836 LDH REAGENT SET Anco Medical Reagents & Assoc. CFH Class II 1981-10-09
K812835 TOTAL CALCIUM REAGENT SET Anco Medical Reagents & Assoc. CIC Class II 1981-10-09
K812699 AMYLASE Pointe Scientific, Inc., KHM Class II 1981-10-06
K812690 C-PEPTIDE CONTROL PACK Mallinckrodt Critical Care JJX Class I 1981-10-06
K812689 RIA QUANT C-PEPTIDE KIT Mallinckrodt Critical Care JKD Class I 1981-10-06
K812604 BIOVATION URINALYSIS REPORTER Biovation, Inc. JQP Class I 1981-10-02
K812601 SQC BUFFER Transidyne General Corp. JJS Class I 1981-10-02
K812593 ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 Harleco CGS Class II 1981-10-02
K812670 SANDARE FAST 340 PHOSPHORUS PROCEDURE Sandare Chemical Co., Inc. CED Class I 1981-10-02
K812677 UNITEST-POTASSIUM Biodynamics Corp. CEJ Class II 1981-10-02
K812641 URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM Reagents Applications, Inc. KNK Class I 1981-10-02
K812635 ANEMIA CONTROL Environmental Chemical Specialties JJY Class I 1981-10-02
K812594 ULTRA ZYME PLUS AMYL #64982 & 65031 Harleco CIJ Class II 1981-10-02
K812647 EMIT AUTO CAROUSEL Syva Co. JQW Class I 1981-10-02
K812666 THYROXINE (T4) 125I Pcl-Ria, Inc. CDP Class II 1981-10-02
K812671 EMBRITROL CK-MB CONTROLS Intl. Immunoassay Laboratories, Inc. JJT Class I 1981-10-02
K812611 QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO Kallestad Laboratories, Inc. CDP Class II 1981-10-02
K812596 ULTRA ZYME PLUS ALP #64962, 65029 & 30 Harleco CJE Class II 1981-09-29
K812595 ULTRA CHEM E-GLU #64976 & 65040 Harleco CFR Class II 1981-09-29
K812592 ULTRA ZYME PLUS GOT #64953, 65033 & 34 Harleco CIT Class II 1981-09-24
K812583 BOVINE CHEMISTRY CONTROL I.X. & II.X. American Dade JJY Class I 1981-09-24
K812227 GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY Clinical Assays, Inc. CFP Class I 1981-09-24
K812589 ULTRA CHEM E-TRIG #65024 Harleco CDT Class I 1981-09-24
K812591 ULTRA ZYME PLUS GPT, #64956, 65035 & 36 Harleco CKA Class I 1981-09-24
K812590 ULTRA ZYME PLUS LDH #64950, 65038 & 39 Harleco CFJ Class II 1981-09-24
K812574 HDL CHOLESTEROL REAGENT Pointe Scientific, Inc., LBR Class I 1981-09-24
K812541 PROTEIN-BASED BLOOD GAS CONTROL American Dade JJS Class I 1981-09-23
K812500 ULTRACHEM URIC ACID ALDH, ITEM #65047 Harleco CDO Class I 1981-09-23
K812553 AQUEOUS BLOOD GAS CONTROLS Fisher Scientific Co., LLC JJS Class I 1981-09-23
K812552 COROMETRICS MEDICAL SYST. 220 PH ANALY. Transidyne General Corp. CHL Class II 1981-09-23
K812505 PALL ULTIPOR VACUUM LINE BACTERIA FITLER Pall Biomedical Products Co. JQC Class I 1981-09-16
K812471 SPIN-CHEM TRIGLYCERIDES REAGENT Smithkline Diagnostics, Inc. CDT Class I 1981-09-14
K812472 SPIN-CHEM LD-L REAGENT Smithkline Diagnostics, Inc. CFJ Class II 1981-09-14
K812417 BLOOD UREA NITROGEN(BUN-UV) Reagents Applications, Inc. CDQ Class II 1981-09-09
K812430 URIC ACID REAGENT SET Pointe Scientific, Inc., KNK Class I 1981-09-09
K812452 ALKALINE PHOSPHATASE Pointe Scientific, Inc., CJE Class II 1981-09-09
K812447 AMYLASE REAGENT KIT Bioscientific KHM Class II 1981-09-09
K811942 J & S IRON SATURATING REAGENT Thyroid Diagnostics, Inc. JQF Class I 1981-09-08
K812303 GLUCOSE-HK SYSTEM PACK TEST Boehringer Mannheim Corp. CFR Class II 1981-09-01
K811959 TANDEM PAP KIT - (PARTS I & II) Hybritech, Inc. JFH Class II 1981-09-01
K812341 UREA NITROGEN (BUN) Pointe Scientific, Inc., CDQ Class II 1981-09-01
K812313 SANDARE URIC ACID PROCEDURE Sandare Chemical Co., Inc. LFQ Class I 1981-09-01
K812334 B-NEOCEPT Organon, Inc. JHJ Class II 1981-09-01
K811342 REAGENT STRIPS FOR URINALYSIS Miles Laboratories, Inc. JRE Class I 1981-09-01
K812293 CENTRICHEM CHOLESTEROL REAGENT & CALIBRA Baker Diagnostics CHH Class I 1981-08-31
K812290 FUN-UV SYSTEM PACK TEST Boehringer Mannheim Corp. CDQ Class II 1981-08-31
K812285 MONOJECT STERILE CORVAC BLOOD TUBE Sherwood Medical Co. JKA Class II 1981-08-31
K812258 ACR ENZYMATIC GLUCOSE OXIDASE Harleco CGA Class II 1981-08-31
K812261 ACCURATE I Organon, Inc. JHJ Class II 1981-08-31
K812308 LANCER BUN RATE REAGENT KIT Sherwood Medical Co. CDS Class II 1981-08-31
K812288 HUMAN C-PEPTIDE REAGENTS Immunex Radiochemical Diagnostics JKD Class I 1981-08-31
K812095 ENXYMATIC CREATININE TEST Boehringer Mannheim Corp. JFY Class II 1981-08-31
K812296 GAMMA GLUTAMY TRANSPEPTIDASE Pointe Scientific, Inc., JQB Class I 1981-08-31
K811805 TRYPIN (125I) RIA KIT Bd Becton Dickinson Vacutainer Systems Preanalytic JNO Class I 1981-08-31
K812156 CONCEP-7-BHCG Leeco Diagnostics, Inc. JHI Class II 1981-08-20
K811764 URIC ACID REAGENT SET Anco Medical Reagents & Assoc. LFQ Class I 1981-08-20
K812246 COAT-A-COUNT T3 RIA KIT Diagnostic Products Corp. CDP Class II 1981-08-20
K812220 NEPHELOMETRIC SOLID TURBIDITY STANDARD Hyland Therapeutic Div., Travenol Laboratories JIW Class II 1981-08-18
K811165 GLUCOSE OXIDASE RATE REAGENT Chem-Elec, Inc. CGA Class II 1981-08-13
K811406 CREATININE RATE REAGENT KIT Chem-Elec, Inc. CGX Class II 1981-08-13
K812109 GILCHEM CREATININE REAGENT Gilford Diagnostics CGX Class II 1981-08-13
K812110 GILCHEM CALCIUM REAGENT Gilford Diagnostics CIC Class II 1981-08-13
K811319 CHLORIDE REAGENT KIT Chem-Elec, Inc. JFS Class II 1981-08-13
K812136 AMERLEX TSH RIA KIT Amersham Corp. JLW Class II 1981-08-13
K811757 NEIA PAP ENZYMEIMMUNOASSAY New England Immunology Assoc. JFH Class II 1981-08-13
K812112 MARRIA-HPRL RIA KIT Intl. Immunoassay Laboratories, Inc. CFT Class I 1981-08-13
K811381 ASTRA Chem-Elec, Inc. JFL Class II 1981-08-13
K812091 FAST CHOLES-CINET Sclavo, Inc. CHH Class I 1981-08-12
K812100 SERALYZER Miles Laboratories, Inc. CHH Class I 1981-08-12
K812081 WAKO NEFA C TEST Wako Chemicals USA, Inc. JLG Class I 1981-08-12
K812028 KODAK EKTACHEM CLIN. CHEM. SLIDES (TP) Eastman Kodak Company CEK Class II 1981-08-03
K812027 KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) Eastman Kodak Company CIW Class II 1981-08-03
K811940 OREIA II, B-HCG Organon, Inc. JHJ Class II 1981-08-03
K812029 KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG) Eastman Kodak Company CDT Class I 1981-08-03
K812030 KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB) Eastman Kodak Company CIX Class II 1981-08-03
K811993 RADIOIMMUNOASSAY, FOLLICLE STIMULATING Endocrine-Metabolic Center CGJ Class I 1981-08-03
K811864 SIGMA PROCEDURE 265-UV Sigma Chemical Co. CED Class I 1981-07-31
K812004 GASTRIN RIA DIAGNOSTIC KIT Abbott Laboratories CGC Class I 1981-07-28
K811954 COMBO-FER IRON DIAGNOSTIC Immuno Assay Corp. JQG Class I 1981-07-27
K811994 RADIOIMMUNOASSAY LUTEINIZING HORMONE Endocrine-Metabolic Center CEP Class I 1981-07-27
K811975 MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL Waters Assoc., Inc. JJQ Class I 1981-07-27
K811941 NEOCEPT Organon, Inc. JHJ Class II 1981-07-27
K811896 902 NA/K Corning Medical & Scientific JGS Class II 1981-07-23
K811886 CESIUM DILUENT 7.5M Gilford Diagnostics JGT Class II 1981-07-23
K811881 KING DIAGNOSTICS TOTAL BILIRUBIN TEST King Diagnostics, Inc. CIG Class II 1981-07-23
K811883 KING DIAGNOSTICS GLUCOSE-O TEST King Diagnostics, Inc. CGE Class II 1981-07-23
K811953 IMMOPHASE INSULIN (125I) RADIOASSAY Corning Medical & Scientific CFP Class I 1981-07-23
K811818 UROPAPER EIKEN UAG Syn-Kit, Inc. JIL Class II 1981-07-23
K811850 ESKAFLOW TEST FOR TRIGLYCERIDES Smithkline Diagnostics, Inc. CDT Class I 1981-07-23
K811919 KODAK EKTACHEM 400 ANALYZER Eastman Kodak Company JJE Class I 1981-07-23
K811912 HELENA VMA-SMC CONTROL Helena Laboratories JJX Class I 1981-07-23
K811907 PROGESTERONE DIRECT RIA KIT (125I) Immunalysis Corporation JLS Class I 1981-07-23
K811906 DHEA-SULFATE DIRECT RIA KIT(125I) Immunalysis Corporation JKC Class I 1981-07-23
K811905 FOLLICLE STIMULATING HORMONE DIRECT RIA Immunalysis Corporation CGJ Class I 1981-07-23

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