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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
LDH-L (K813496)Pointe Scientific, Inc.,1981-12-31
IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY (K813525)Micromedic Systems1981-12-31
ULTRACHEM GLUC-DH (K813427)Harleco1981-12-31
LIPID PROFILE (K813469)Bio-Analytics Laboratories, Inc.1981-12-31
BLOOD GAS ANALYSIS, STANDARDS CONTROLS (K813517)United Diagnostics, Inc.1981-12-31
CENTIDISC (K813524)Bel-Art Products1981-12-31
URIC-ACID (K813511)Medical Analysis Systems, Inc.1981-12-31
FREE T4 RIA TEST SET (K813465)Ventrex Laboratories, Inc.1981-12-31
LS 5800 SERIES LIQUID SCINTILLATION (K813472)Beckman Instruments, Inc.1981-12-29
AMMONIA TEST (K813366)Wako Pure Chemical Industries, Ltd.1981-12-22
PROGESTERONE KIT BY RIA (K813484)Immuchem Corp.1981-12-22
RADIOIMMUNOASSAY FOR HUMAN THYROID (K813392)Leeco Diagnostics, Inc.1981-12-22
SHARIA-LH RIA KIT FOR QUANTITATION HORMO (K813213)Intl. Immunoassay Laboratories, Inc.1981-12-22
ELECTROLYTE GEL (K813370)Hi Chem, Inc.1981-12-22
MULTIWASH (K813426)Flow Laboratories, Inc.1981-12-22
COAT-A-COUNT TESTOSTERONE RIA KIT (K813401)Diagnostic Products Corp.1981-12-22
TRIGLYCERIDE CALIBRATORS (K813478)Gilford Diagnostics1981-12-22
CPK(CK) IN VITRO DIAG. REAGENT SET (K813406)Pointe Scientific, Inc.,1981-12-22
AST(SGOT) IN VITRO DIAG. REAGENT SET (K813405)Pointe Scientific, Inc.,1981-12-22
INORGANIC PHOSPHORUS REAGENT SET (K813400)Anco Medical Reagents & Assoc.1981-12-22
DOCUMENT LINEARITY TEST STANDARDS (K813411)North American Standards1981-12-18
MINI-SHAKER (K813318)Dynatech Corp.1981-12-17
RIAGEN PAP RIA (K813261)Biogenex Laboratories1981-12-17
ANDRIA-FSH RIA TEST KIT (K813086)Intl. Immunoassay Laboratories, Inc.1981-12-17
A-1 IN-HOME PREGNANCY TEST (K813272)C.F. Medical, Inc.1981-12-17
A-1 TEST (K812788)C.F. Medical, Inc.1981-12-17
ORTHO CO2 DILUENT LEVEL I (K813293)Ortho Diagnostic Systems, Inc.1981-12-17
ASTRA REAGENT CONCENTRATE SYSTEM (K812866)Nobel Scientific Industries, Inc.1981-12-17
ACU-SLIDE TEST (K812789)C.F. Medical, Inc.1981-12-17
ORTHO* UNASSAYED CONTROL SERUM LEVEL I (K813321)Ortho Diagnostic Systems, Inc.1981-12-17
ORTHO CO2 DILUENT LEVEL II (K813294)Ortho Diagnostic Systems, Inc.1981-12-17
SECURE FDI TEST KIT (K813216)Beckman Instruments, Inc.1981-12-17
ORTHO CO2 DILUENT LEVEL III (K813295)Ortho Diagnostic Systems, Inc.1981-12-17
NO-HOIL COMBOSTAT II KIT (K813310)Ria Products, Inc.1981-12-17
ABURIA-CK RIA TEST KIT (K813087)Intl. Immunoassay Laboratories, Inc.1981-12-17
ORTHO* UNASSAYED CONTROL SERUM LEVEL III (K813322)Ortho Diagnostic Systems, Inc.1981-12-17
BECKMAN SYSTEM E4A (K813160)Beckman Instruments, Inc.1981-12-10
UV URIC ACID DETERMINATION (K813244)Biorent Diagnostic, Inc.1981-12-08
VACUSHIELD TM (K813159)Gelman Sciences, Inc.1981-12-08
UROPAPER EIKEN UHAG (K811816)Syn-Kit, Inc.1981-12-08
HDL CHOLESTEROL REAGENT SET (K812839)Anco Medical Reagents & Assoc.1981-12-03
SERUM IRON REAGENT SET (K812840)Anco Medical Reagents & Assoc.1981-12-03
C-TERMINAL PTH RIA TEST KIT, DSL-1000 (K813203)Diagnostic Systems Laboratories, Inc.1981-12-03
PHENYLALANINE UV KINETIC TEST KIT (K813171)Biochemicals, Inc.1981-12-03
LIQUIZYME GLUCOSE REAGENT (K813168)American Research Products Co.1981-12-03
CREATININE REAGENT SET (K812834)Anco Medical Reagents & Assoc.1981-12-03
TRIGLYCERIDE REAGENT SET (K812838)Anco Medical Reagents & Assoc.1981-12-03
HDL-C EIKEN (K813192)Syn-Kit, Inc.1981-11-27
TOTAL PROTEIN REAGENT SET (K812833)Anco Medical Reagents & Assoc.1981-11-27
TOTAL & DIRECT BILIRUBIN REAGENT SET (K812841)Anco Medical Reagents & Assoc.1981-11-27
SYVA ADVANCE TM FLUOROMETER (K813146)Syva Co.1981-11-27
VITAMIN B12/FOLATE DUAL RADIOASSAY KITS (K812979)Amersham Corp.1981-11-24
S/P VORTEX MIXER JR. (K813149)American Dade1981-11-24
S/P VORTEX MIXER (K813148)American Dade1981-11-24
ORTHO UNASSAYED CONTROL SERUM LEVEL II (K813167)Ortho Diagnostic Systems, Inc.1981-11-24
POLI-MAK II (K813102)Pm America, Inc.1981-11-24
TECHNICON RA 1000 SYSTEM (K813077)Technicon Corp.1981-11-16
LEECO TESTO-QUANT DIAG. KIT (K813059)Leeco Diagnostics, Inc.1981-11-16
PHOSPHOTUNGSTATE REDUCTION, URIC ACID (K813076)American Monitor Corp.1981-11-16
ULTRACHEM CA, ITEM #64975 (K813040)Harleco1981-11-10
ULTRACHEM ALB, ITEM #64970 (K813044)Harleco1981-11-10
ULTRACHEM E-CHOL, ITEM #65025 (K813039)Harleco1981-11-10
LORENZ BLOOD GAS ANALYZER (K812090)Lorenz Instruments1981-11-10
ULTRACHEM TP, ITEM #64974 (K813038)Harleco1981-11-10
ULTRACHEM CREA ITEM #64972 (K813043)Harleco1981-11-10
ULTRAZYME-GT, ITEM #64959 & 65032 (K813041)Harleco1981-11-10
QUANTUMATIC DUAL-WAVELENGTH SPECTRO (K812865)Abbott Laboratories1981-11-10
DSD (K812983)Pm America, Inc.1981-11-10
ULTRACHEM GLUC-DH SET, ITEM #65048 (K813042)Harleco1981-11-10
ALT-QUANTICHROM (K812926)Abbott Laboratories1981-11-06
URIC ACID SYSTEM PACK TEST (K812978)Boehringer Mannheim Corp.1981-11-06
LIQUILYME BUN REAGENT (K812945)Amresco, Inc.1981-11-06
ACCURATE BETA (K812967)Organon, Inc.1981-11-06
URICAR (K812700)Hi Chem, Inc.1981-11-05
GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT (K812727)Immuno Nuclear Corp.1981-11-05
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C (K812556)American Dade1981-11-02
CLEANING SOLUTION FOR RADIOMETER OSM2 (K812623)Fisher Scientific Co., LLC1981-11-02
GILCHEM ALP REAGENT (K812912)Gilford Diagnostics1981-11-02
MULTI-GRAM DEVELOPING TANK R-12 & R-3 (K812919)Marion Laboratories, Inc.1981-11-02
ANSWER (R) (K812924)Armkel, LLC1981-11-02
OPTIONAL TOTAL CA-MODULE FOR IL 504/508 (K812872)Instrumentation Laboratory CO1981-10-26
CHOLESTEROL CALIBRATORS (K812861)Gilford Diagnostics1981-10-23
DISPENSER ASPIRATOR DA 300 (K812782)Pharmacia, Inc.1981-10-23
LIPASE (K812794)Pointe Scientific, Inc.,1981-10-20
IL 501, NA/K ANALYZER (K812762)Instrumentation Laboratory CO1981-10-20
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD (K812784)Beckman Instruments, Inc.1981-10-20
BECKMAN ICS CALIBRATOR (K812649)Beckman Instruments, Inc.1981-10-19
DIRECT IRON REAGENT SET (K812777)The Dow Chemical Co.1981-10-19
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN (K812754)Beckman Instruments, Inc.1981-10-19
NML CK-MB RIA (K812759)Nuclear Medical Laboratories, Inc.1981-10-19
BECKMAN ICS NORMAL CONTROL SERA (K812650)Beckman Instruments, Inc.1981-10-19
TANDEM QUALITATIVE HCG KIT (K812461)Hybritech, Inc.1981-10-13
LDH REAGENT SET (K812836)Anco Medical Reagents & Assoc.1981-10-09
TOTAL CALCIUM REAGENT SET (K812835)Anco Medical Reagents & Assoc.1981-10-09
RIA QUANT C-PEPTIDE KIT (K812689)Mallinckrodt Critical Care1981-10-06
AMYLASE (K812699)Pointe Scientific, Inc.,1981-10-06
C-PEPTIDE CONTROL PACK (K812690)Mallinckrodt Critical Care1981-10-06
ANEMIA CONTROL (K812635)Environmental Chemical Specialties1981-10-02
SQC BUFFER (K812601)Transidyne General Corp.1981-10-02
EMIT AUTO CAROUSEL (K812647)Syva Co.1981-10-02
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