Atlas FDA

Clinical Chemistry

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

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RecordFirmDate
PREG-KNOW (K821552)Immuno Pathology Labs1982-06-11
EMIT TIMER UNIT #100 (K821531)Syva Co.1982-06-11
TANDEM PROLACTIN KIT (K821545)Hybritech, Inc.1982-06-11
LANCER MSA BUN DIAG. KIT (K821562)Sherwood Medical Co.1982-06-11
TANDEM - HGH KIT (K821366)Hybritech, Inc.1982-06-10
HEMATOLOGY DATA MANAGEMENT SYS (K821534)Biovation, Inc.1982-06-10
TITANAN GEL SERUM PROTEIN ELECTROPHORES (K821517)Helena Laboratories1982-06-10
IL 1302 PH BLOOD GAS ANALYZER (K821483)Instrumentation Laboratory CO1982-06-10
ACID PHOSPHATASE REAGENT SET (K821526)Anco Medical Reagents & Assoc.1982-06-10
ULTRACHEM URIC ACID AIDH #65047 (K821474)Emd Chemicals, Inc.1982-06-03
RIA STAT 16 (K821494)E. R. Squibb & Sons, Inc.1982-06-03
ULTRAZYME PLUS CKI, #64978,65027&65028 (K821473)Emd Chemicals, Inc.1982-06-03
CARDIOZYME PLUS CK-MB, #65045 (K821464)Emd Chemicals, Inc.1982-06-02
ULTRACHEM URIC ACID AIDH, #65047 (K821465)Emd Chemicals, Inc.1982-06-02
PREG/TEX PREGNANCY TEST (K821387)Texas Immunology, Inc.1982-06-02
RADIOIMMUNOASSAY PARATHYROID HORMONE MID (K821131)Endocrine-Metabolic Center1982-06-02
ULTRACHEM GLUC-DH, #65048 (K821463)Emd Chemicals, Inc.1982-06-02
BECKMAN LIQUID-STAT AST-UV LIQUID (K821433)Beckman Instruments, Inc.1982-06-02
ULTRAZYME PLUS-GT, #64959 & 65032 (K821468)Emd Chemicals, Inc.1982-06-02
ULTRAZYME PLUS ALP #64962,65029&65030 (K821471)Emd Chemicals, Inc.1982-06-02
ULTRACHEM E-GLU #64976 & 65040 (K821470)Emd Chemicals, Inc.1982-06-02
ULTRACHEM E-GLU, #64976 & 65040 (K821461)Emd Chemicals, Inc.1982-06-02
ULTRACHEM GLUC-DH, #65048 (K821469)Emd Chemicals, Inc.1982-06-02
SPAC T4 RIA TEST KIT (K820725)Mallinckrodt Critical Care1982-06-01
ULTRAZYME PLUS LDH, #64950,65038&65039 (K821466)Emd Chemicals, Inc.1982-06-01
ULTRAZYME PLUS CK-I, #64978,65027&65028 (K821460)Emd Chemicals, Inc.1982-06-01
MR 600 MICROPLATE READER (K821439)Dynatech Corp.1982-06-01
FREE T4 RADIOIMMUNOASSAY KIT (K821241)Bioclinical Group1982-06-01
ULTRAZYME PLUS GOT, #64953,65033&65034 (K821467)Emd Chemicals, Inc.1982-06-01
ULTRACHEM T-BILI, #64971 (K821462)Emd Chemicals, Inc.1982-06-01
ENZYMATIC CHOLESTERAL OXIDASE #650550 (K821441)Emd Chemicals, Inc.1982-06-01
VERSACHEM ANALYZER (K821561)Emd Chemicals, Inc.1982-06-01
QUANTIMUNE HLH RIA (K821346)Bio-Rad1982-05-28
ENZYMUNE-TEST INSULIN (K821374)Icl Scientific1982-05-28
SERIES 4 LIQUID CHROMATOGRAPH (K821219)The Perkin-Elmer Corp.1982-05-28
CHEMISTRY CONTROL/STANDARD (K821382)Medical Analysis Systems, Inc.1982-05-28
ULTRAZYME PLUS AMYL #65031&64982 (K821459)Emd Chemicals, Inc.1982-05-28
SPIN CHEM REAGENTS & STANDARDS (K821184)Smithkline Diagnostics, Inc.1982-05-24
DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM (K821315)The Dow Chemical Co.1982-05-24
MICROLYTE (K820541)Kone Instruments, Inc.1982-05-24
PROLACTIN (125-I) RADIOIMMUNOASSAY KIT (K821305)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-05-24
ACCUDEX REAGENT STRIPS (K821247)Miles Laboratories, Inc.1982-05-21
RIAGEN B-HCG RIA (K821234)Biogenex Laboratories1982-05-21
ALBUMIN REAGENT (K821225)Hi Chem, Inc.1982-05-21
RESPONSE LIQUID LIGAND ASSAY SERUM (K821242)Beckman Instruments, Inc.1982-05-21
LIQUID-STAT LIQUID ENZYME REAGENT (K821240)Beckman Instruments, Inc.1982-05-21
URIC ACID REAGENT SET(ENZYMATIC (K821214)Omega Medical Electronics1982-05-21
TSH-SQUIBB RADIOIMMUNOASSAY KIT (K821174)Squibb & Sons, Inc.1982-05-14
VISIDEX REAGENT STRIPS (K821179)Miles Laboratories, Inc.1982-05-14
GASTRIN RADIOIMMUNOASSAY KIT (125-I) (K821175)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-05-14
URICASE (U.V.) URIC ACID (K821167)Syn-Kit, Inc.1982-05-14
8700 CLINICAL CHEM. ANALYZER (K820888)Boehringer Mannheim Corp.1982-05-14
I-DHEA-SULFATE RIA KIT 125 (K821145)Nuclear Medical Systems, Inc.1982-05-14
ACCUCHEK BG. (K821091)Biodynamics Corp.1982-05-14
TARGET ISOCHECK CONTROL SERUM (K821183)Smithkline Diagnostics, Inc.1982-05-14
ENDAB T4 ENZYME IMMUNOASSAY KIT (K821141)Immunotech Corp.1982-05-13
HI-PHORE HIGH RESOLUTION ELECTROPHORES (K821303)Gelman Sciences, Inc.1982-05-12
FETAL-TEK CONTROL (IMMATURE/BORDERLINE) (K820772)Helena Laboratories1982-05-12
SIMUL-FER SERUM IRON TEST KIT (K820253)Diagnostic Reagents, Inc.1982-05-12
MEGNESIUM REAGENT KIT (K821102)Anco Medical Reagents & Assoc.1982-05-05
CHOLESTEZYME-V EIKEN (K821105)Syn-Kit, Inc.1982-05-05
DSL 1020 (K821068)Diagnostic Systems Laboratories, Inc.1982-05-05
TOTAL RADIOIMMUNOASSAY KIT (K821101)Bioclinical Group1982-05-05
AUTOMATED URINALYSIS SYSTEM (K813056)Kyoto Daiichi Kagaku Co., Ltd.1982-05-05
BIOSTRIP G (K820594)Helena Laboratories1982-05-05
TRIGLYZYME V EIKEN (K821106)Syn-Kit, Inc.1982-05-05
T4 DIAGNOSTIC KIT (K820251)Diagnostic Reagents, Inc.1982-05-05
TBG DIAGNOSTIC KIT (K820252)Diagnostic Reagents, Inc.1982-05-05
LIQUID-STAT TM AST-UV LIQUID ENZUNE (K821048)Beckman Instruments, Inc.1982-05-03
RA-1000 SYSTEM ADD'L ANALYTES PHASE III (K820913)Technicon Instruments Corp.1982-05-03
UNI-PUMP 200 (K821039)Scientific Mfg. Industries, Inc.1982-05-03
NOVA II FLUIDS PACK (K821030)Shaban Mfg. Co.1982-05-03
ACE ALBUMIN CALIBRATOR (K821061)E.I. Dupont DE Nemours & Co., Inc.1982-05-03
ACE ACTIVITY MICROVIAL TEST SET (K821011)Ventrex Laboratories, Inc.1982-05-03
SKATRON REPEATING DISPENSER (K821034)Skatron, Inc.1982-05-03
ROCHE(R) B-HCG RIA URINE STANDARD (K820942)Hoffmann-La Roche, Inc.1982-05-03
715 DELTA TERMINAL (K821058)Corning Medical & Scientific1982-05-03
AMERLEX B-LCG RIA KIT (K821031)Amersham Corp.1982-05-03
ECLIPSE (K821007)Scientific Software & Instrument Co.1982-05-03
TANDEM HCG KIT (K820822)Hybritech, Inc.1982-04-29
GILCHEM ACID PHOSPHATASE REAGENT (K820975)Gilford Diagnostics1982-04-26
NOVA III FLUIDS PACK (K820947)Shaban Mfg. Co.1982-04-26
GIL CHEM MAGNESIUM REAGENT (K820976)Gilford Diagnostics1982-04-26
ENZYMATIC CHOLESTEROL KIT (K820951)Anco Medical Reagents & Assoc.1982-04-26
TOTAL CHOLESTEROL REAGENT SET (K820950)Sterling Biochemical, Inc.1982-04-26
CORNING CERTAIN TM (K820873)Corning Medical & Scientific1982-04-16
LH RADIOIMMUNOASSAY TEST SYSTEM (K820760)Monobind1982-04-16
THYROXINE T4 KIT (K820886)Pcl-Ria, Inc.1982-04-16
ENZYME-TEST TBC T4 UPTAKE (K820879)Icl Scientific1982-04-16
SERALYZER CK REAGENT STRIPS (K820880)Miles Laboratories, Inc.1982-04-16
PHOSPHORUS IL (K820832)American Monitor Corp.1982-04-15
AMERLEX ESH KIT (K820754)Amersham Corp.1982-04-15
ENZYM-LINKED T3 (K820763)Icl Scientific1982-04-15
IL MODEL 1301, PH BLOOD GAS SYSTEM (K820744)Instrumentation Laboratory CO1982-04-15
COLORIMETRIC LDH REAGENT SET (K820768)Biorent Diagnostic, Inc.1982-04-14
MR1 LUTROPIN RIA KIT (K820741)Microanalytic Research, Inc.1982-04-14
FLUOROGEN PAP FIA (K820724)Biogenex Laboratories1982-04-14
CREATINE KINASE-MB KIT (K820812)Calbiochem-Behring Corp.1982-04-12
AMERLEX LH RIA KIT (CODE IM2081) (K820753)Amersham Corp.1982-04-09
POLI-MAK MODEL F-4 (FINAL (K820748)Pm America, Inc.1982-04-06
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