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

    PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT

    K Number: K811169 · Decision May 15, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    44
    Applicant Total
    94
    Review Days
    17

    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
    PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT
    K Number
    K811169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Amersham Corp.
    Date Received
    April 28, 1981
    Decision Date
    May 15, 1981
    Product Code
    JFH
    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
    JFH Acid Phosphatase (Prostatic), Tartrate Inhibited

    Similar 510(k) Clearances

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

    IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMMULITE PAP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMX PAP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO

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

    Other Clearances by Amersham Corp.

    K Number Device Name
    K914135 AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
    K912733 AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
    K912766 AMERLITE CK-MB ASSAY
    K904666 AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
    K902760 AMERSHAM TSH CONTROL SERA
    K901854 GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)
    K901857 GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)
    K901848 GADOLINIUM-153 BONE DENSITOMETER SOURCES
    K901832 GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415
    K896270 AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
    Search all 94 clearances from Amersham Corp. →