INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST— 510(k) K880148

Name: FDA 510(k) clearance K880148
Creator: U.S. Food and Drug Administration
Published: 1988-02-10

Substantially Equivalent

Ampcor, Inc.

FDA 510(k) clearance K880148 for INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST, Substantially Equivalent on 1988-02-10. Applicant: Ampcor, Inc.. Device class: 2.

Clearance details

Applicant: Ampcor, Inc.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1988-01-13
Decision date: 1988-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ampcor, Inc.

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K922296 — IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST1992-07-14
K922297 — INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST1992-07-14
K910438 — DIPSTICK SALMONELLA1991-09-13
K893873 — SINGLE AND DUAL BAND DIPSTICK HCG TEST1989-08-21
K890048 — QUIK-DOT TOXOPLASMOSIS1989-06-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.