QUIK-DOT TOXOPLASMOSIS— 510(k) K890048

Substantially Equivalent

Ampcor, Inc.

FDA 510(k) clearance K890048 for QUIK-DOT TOXOPLASMOSIS, Substantially Equivalent on 1989-06-09. Applicant: Ampcor, Inc.. Device class: 2.

Clearance details

Applicant: Ampcor, Inc.
Product code: Code LLA
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1989-01-06
Decision date: 1989-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLA

K913467 — TOXOGEN1993-01-11
K850768 — TOXOSCAN CARD TEST KIT1985-05-20
K831930 — TOXO-SCREEN DA TEST1983-09-26

More clearances from Ampcor, Inc.

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
K892119 — QUIK-DOT C REACTIVE PROTEIN1989-04-14

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