BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SERALYZER BLOOD UREA NITROGEN(BUN)

    K Number: K801269 · Decision Jul 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    10
    Applicant Total
    158
    Review Days
    41

    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
    SERALYZER BLOOD UREA NITROGEN(BUN)
    K Number
    K801269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Miles Laboratories, Inc.
    Date Received
    May 28, 1980
    Decision Date
    July 8, 1980
    Product Code
    JGZ
    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
    JGZ O-Phthalaldehyde, Urea Nitrogen

    Similar 510(k) Clearances

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

    ROCHE COBAS READY RENAL PROFILE REAGENT STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COBAS READY BUN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IQ UREA NITROGEN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PHARMACIA B2-MICRO RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BLOOD UREA NITROGEN REAGENT SYS

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

    Other Clearances by Miles Laboratories, Inc.

    K Number Device Name
    K880605 LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
    K874909 MICRO-BUMINTEST REAGENT TABLETS
    K875079 MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
    K871835 GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
    K872120 SERALYZER III BLOOD CHEMISTRY ANALYZER
    K873304 CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
    K872634 CUTTER PUREFLO PLUS IV FILTER
    K870214 MODIFIED SALTEX REAGENT STRIPS
    K870752 SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
    K865053 SERA-TEK MICROSOMAL ANTIBODY TEST
    Search all 158 clearances from Miles Laboratories, Inc. →