meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
63
Latest Decision
1982-01-18

Clearances · page 110 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K813573 CARDIOTRAC CORNING CK ISOENZYME SUBST Corning Medical & Scientific JHX Class II 1982-01-18
K813555 GLUCOSE ENZYME-COLOR REAGENT SET Biorent Diagnostic, Inc. CGA Class II 1982-01-18
K813580 Q-LINE LTC Miles Laboratories, Inc. JJY Class I 1982-01-18
K813575 LIQUID CHROMATOGRAPHY (HPLC) COLUMNS Supelco, Inc. DPM Class I 1982-01-18
K813469 LIPID PROFILE Bio-Analytics Laboratories, Inc. CFD Class I 1981-12-31
K813540 A FLUOROMETER American Diagnostic Corp. KHO Class I 1981-12-31
K813495 ALT (SGPT) Pointe Scientific, Inc., CKA Class I 1981-12-31
K813525 IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY Micromedic Systems JLW Class II 1981-12-31
K813465 FREE T4 RIA TEST SET Ventrex Laboratories, Inc. CEC Class II 1981-12-31
K813427 ULTRACHEM GLUC-DH Harleco LFR Class II 1981-12-31
K813412 GLUCOSE ENZYME-COLOR REAGENT SET Diagnostic Specialties CGA Class II 1981-12-31
K813496 LDH-L Pointe Scientific, Inc., CFJ Class II 1981-12-31
K813449 PHE/TYR KINETIC UV TEST SET P-L Biochemicals, Inc. JNB Class II 1981-12-31
K813517 BLOOD GAS ANALYSIS, STANDARDS CONTROLS United Diagnostics, Inc. CHL Class II 1981-12-31
K813529 DADE COLORIMETRIC AMYLASE American Dade CIJ Class II 1981-12-31
K813447 SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR Rna Medical Corp. JIS Class II 1981-12-31
K813536 ASTRA TOTAL PROTEIN REAGENT Hi Chem, Inc. CEK Class II 1981-12-31
K813415 UREA NITROGEN REAGENT SET Anco Medical Reagents & Assoc. CDW Class II 1981-12-31
K813505 FLAME PHOTOMETER CALIBRATION STANDARDS Fisher Scientific Co., LLC JIS Class II 1981-12-31
K813523 ELECTRIC SELF STERILIZATION INOCUL. LOOP Techhnilab Instruments, Inc. LTB Class II 1981-12-31
K813511 URIC-ACID Medical Analysis Systems, Inc. KNK Class I 1981-12-31
K813524 CENTIDISC Bel-Art Products JQC Class I 1981-12-31
K813472 LS 5800 SERIES LIQUID SCINTILLATION Beckman Instruments, Inc. JJJ Class I 1981-12-29
K813484 PROGESTERONE KIT BY RIA Immuchem Corp. JLS Class I 1981-12-22
K813401 COAT-A-COUNT TESTOSTERONE RIA KIT Diagnostic Products Corp. CDZ Class I 1981-12-22
K813392 RADIOIMMUNOASSAY FOR HUMAN THYROID Leeco Diagnostics, Inc. JLW Class II 1981-12-22
K813400 INORGANIC PHOSPHORUS REAGENT SET Anco Medical Reagents & Assoc. CEO Class I 1981-12-22
K813478 TRIGLYCERIDE CALIBRATORS Gilford Diagnostics JIS Class II 1981-12-22
K813366 AMMONIA TEST Wako Pure Chemical Industries, Ltd. JID Class I 1981-12-22
K813213 SHARIA-LH RIA KIT FOR QUANTITATION HORMO Intl. Immunoassay Laboratories, Inc. CEP Class I 1981-12-22
K813405 AST(SGOT) IN VITRO DIAG. REAGENT SET Pointe Scientific, Inc., CIT Class II 1981-12-22
K813370 ELECTROLYTE GEL Hi Chem, Inc. CGA Class II 1981-12-22
K813406 CPK(CK) IN VITRO DIAG. REAGENT SET Pointe Scientific, Inc., JHS Class II 1981-12-22
K813426 MULTIWASH Flow Laboratories, Inc. JQW Class I 1981-12-22
K813411 DOCUMENT LINEARITY TEST STANDARDS North American Standards JIX Class II 1981-12-18
K813295 ORTHO CO2 DILUENT LEVEL III Ortho Diagnostic Systems, Inc. JJY Class I 1981-12-17
K813272 A-1 IN-HOME PREGNANCY TEST C.F. Medical, Inc. LCX Class II 1981-12-17
K812788 A-1 TEST C.F. Medical, Inc. JHJ Class II 1981-12-17
K813294 ORTHO CO2 DILUENT LEVEL II Ortho Diagnostic Systems, Inc. JJY Class I 1981-12-17
K813086 ANDRIA-FSH RIA TEST KIT Intl. Immunoassay Laboratories, Inc. CGJ Class I 1981-12-17
K813310 NO-HOIL COMBOSTAT II KIT Ria Products, Inc. CDD Class II 1981-12-17
K813322 ORTHO* UNASSAYED CONTROL SERUM LEVEL III Ortho Diagnostic Systems, Inc. JJY Class I 1981-12-17
K813087 ABURIA-CK RIA TEST KIT Intl. Immunoassay Laboratories, Inc. JHX Class II 1981-12-17
K813321 ORTHO* UNASSAYED CONTROL SERUM LEVEL I Ortho Diagnostic Systems, Inc. JJY Class I 1981-12-17
K813318 MINI-SHAKER Dynatech Corp. JRQ Class I 1981-12-17
K813216 SECURE FDI TEST KIT Beckman Instruments, Inc. JHG Class II 1981-12-17
K812866 ASTRA REAGENT CONCENTRATE SYSTEM Nobel Scientific Industries, Inc. CGA Class II 1981-12-17
K813261 RIAGEN PAP RIA Biogenex Laboratories JFH Class II 1981-12-17
K812789 ACU-SLIDE TEST C.F. Medical, Inc. JHJ Class II 1981-12-17
K813293 ORTHO CO2 DILUENT LEVEL I Ortho Diagnostic Systems, Inc. JJY Class I 1981-12-17
K813160 BECKMAN SYSTEM E4A Beckman Instruments, Inc. JJE Class I 1981-12-10
K811816 UROPAPER EIKEN UHAG Syn-Kit, Inc. JIL Class II 1981-12-08
K813244 UV URIC ACID DETERMINATION Biorent Diagnostic, Inc. CDO Class I 1981-12-08
K813159 VACUSHIELD TM Gelman Sciences, Inc. JRL Class I 1981-12-08
K813168 LIQUIZYME GLUCOSE REAGENT American Research Products Co. CGA Class II 1981-12-03
K812839 HDL CHOLESTEROL REAGENT SET Anco Medical Reagents & Assoc. LBR Class I 1981-12-03
K813171 PHENYLALANINE UV KINETIC TEST KIT Biochemicals, Inc. JNB Class II 1981-12-03
K812840 SERUM IRON REAGENT SET Anco Medical Reagents & Assoc. JIY Class I 1981-12-03
K812838 TRIGLYCERIDE REAGENT SET Anco Medical Reagents & Assoc. CDT Class I 1981-12-03
K812834 CREATININE REAGENT SET Anco Medical Reagents & Assoc. CGX Class II 1981-12-03
K813203 C-TERMINAL PTH RIA TEST KIT, DSL-1000 Diagnostic Systems Laboratories, Inc. CEW Class II 1981-12-03
K812841 TOTAL & DIRECT BILIRUBIN REAGENT SET Anco Medical Reagents & Assoc. CIG Class II 1981-11-27
K813192 HDL-C EIKEN Syn-Kit, Inc. LBS Class I 1981-11-27
K813146 SYVA ADVANCE TM FLUOROMETER Syva Co. KHO Class I 1981-11-27
K812833 TOTAL PROTEIN REAGENT SET Anco Medical Reagents & Assoc. CEK Class II 1981-11-27
K813148 S/P VORTEX MIXER American Dade JRQ Class I 1981-11-24
K812979 VITAMIN B12/FOLATE DUAL RADIOASSAY KITS Amersham Corp. CGN Class II 1981-11-24
K813102 POLI-MAK II Pm America, Inc. JJE Class I 1981-11-24
K813149 S/P VORTEX MIXER JR. American Dade JRQ Class I 1981-11-24
K813167 ORTHO UNASSAYED CONTROL SERUM LEVEL II Ortho Diagnostic Systems, Inc. JJY Class I 1981-11-24
K813059 LEECO TESTO-QUANT DIAG. KIT Leeco Diagnostics, Inc. CDZ Class I 1981-11-16
K813077 TECHNICON RA 1000 SYSTEM Technicon Corp. JJC Class I 1981-11-16
K813076 PHOSPHOTUNGSTATE REDUCTION, URIC ACID American Monitor Corp. CDH Class I 1981-11-16
K812983 DSD Pm America, Inc. JQW Class I 1981-11-10
K812865 QUANTUMATIC DUAL-WAVELENGTH SPECTRO Abbott Laboratories JJQ Class I 1981-11-10
K813043 ULTRACHEM CREA ITEM #64972 Harleco CGX Class II 1981-11-10
K813038 ULTRACHEM TP, ITEM #64974 Harleco CEK Class II 1981-11-10
K812090 LORENZ BLOOD GAS ANALYZER Lorenz Instruments CHL Class II 1981-11-10
K813039 ULTRACHEM E-CHOL, ITEM #65025 Harleco CHH Class I 1981-11-10
K813044 ULTRACHEM ALB, ITEM #64970 Harleco CIX Class II 1981-11-10
K813041 ULTRAZYME-GT, ITEM #64959 & 65032 Harleco JQB Class I 1981-11-10
K813040 ULTRACHEM CA, ITEM #64975 Harleco CJY Class II 1981-11-10
K813042 ULTRACHEM GLUC-DH SET, ITEM #65048 Harleco LFR Class II 1981-11-10
K812926 ALT-QUANTICHROM Abbott Laboratories CKA Class I 1981-11-06
K812945 LIQUILYME BUN REAGENT Amresco, Inc. LFP Class II 1981-11-06
K812967 ACCURATE BETA Organon, Inc. JHJ Class II 1981-11-06
K812978 URIC ACID SYSTEM PACK TEST Boehringer Mannheim Corp. KNK Class I 1981-11-06
K812727 GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT Immuno Nuclear Corp. CGC Class I 1981-11-05
K812700 URICAR Hi Chem, Inc. KNK Class I 1981-11-05
K812556 DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C American Dade JJY Class I 1981-11-02
K812924 ANSWER (R) Armkel, LLC JHJ Class II 1981-11-02
K812919 MULTI-GRAM DEVELOPING TANK R-12 & R-3 Marion Laboratories, Inc. DKK Class I 1981-11-02
K812623 CLEANING SOLUTION FOR RADIOMETER OSM2 Fisher Scientific Co., LLC CHL Class II 1981-11-02
K812912 GILCHEM ALP REAGENT Gilford Diagnostics CJE Class II 1981-11-02
K812872 OPTIONAL TOTAL CA-MODULE FOR IL 504/508 Instrumentation Laboratory CO CIS Class II 1981-10-26
K812782 DISPENSER ASPIRATOR DA 300 Pharmacia, Inc. JQW Class I 1981-10-23
K812861 CHOLESTEROL CALIBRATORS Gilford Diagnostics JIS Class II 1981-10-23
K812784 BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD Beckman Instruments, Inc. CIG Class II 1981-10-20
K812762 IL 501, NA/K ANALYZER Instrumentation Laboratory CO JGS Class II 1981-10-20
K812794 LIPASE Pointe Scientific, Inc., CET Class I 1981-10-20

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