BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH

    K Number: K864659 · Decision Feb 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    5
    Review Days
    68

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH
    K Number
    K864659
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bio Mega Diagnostic, Inc.
    Date Received
    November 28, 1986
    Decision Date
    February 4, 1987
    Product Code
    JLW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JLW), ordered by most recent decision date.

    Atellica® IM TSH3-Ultra II (TSH3ULII)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur® TSH3-Ultra II (TSH3ULII)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Bio Mega Diagnostic, Inc.

    K Number Device Name
    K822438 BIOMEGA MODEL 59W
    K813556 MOD. 587 BLOOD PRESSURE & PULSE MONITOR
    K801923 BIOMEGA #423-B BLOOD PRESSURE & PULSE CK
    K760930 BLOOD PRESSURE & PULSE CHECKER