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510(k) K890048

QUIK-DOT TOXOPLASMOSIS by Ampcor, Inc. — Product Code LLA

K890048 is an FDA 510(k) premarket notification submitted by Ampcor, Inc. for the device "QUIK-DOT TOXOPLASMOSIS". The FDA issued a decision of Substantially Equivalent on June 9, 1989. The device falls under product code LLA (Direct Agglutination Test, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Ampcor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1989
Date Received
January 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Direct Agglutination Test, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

Other clearances by Ampcor, Inc.

  • K922296 — IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST (July 14, 1992)
  • K922297 — INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST (July 14, 1992)
  • K910438 — DIPSTICK SALMONELLA (September 13, 1991)
  • K893873 — SINGLE AND DUAL BAND DIPSTICK HCG TEST (August 21, 1989)
  • K892146 — C REACTIVE PROTEIN LIQUID (April 14, 1989)
  • K892119 — QUIK-DOT C REACTIVE PROTEIN (April 14, 1989)
  • K890025 — QUIK-DOT ANTISTREPTOLYSIN-O (January 31, 1989)
  • K884750 — GROUP A STREP, BETA-STREP (December 22, 1988)
  • K880163 — PREGNANCY (HCG) CARD & LIQUID TEST (May 17, 1988)
  • K880478 — PREGNANCY BETA-HCG CARD & LIQUID TEST (April 28, 1988)

Other clearances for product code LLA

  • K913467 — TOXOGEN (January 11, 1993)
  • K850768 — TOXOSCAN CARD TEST KIT (May 20, 1985)
  • K831930 — TOXO-SCREEN DA TEST (September 26, 1983)

FDA data resources