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510(k) K890025

QUIK-DOT ANTISTREPTOLYSIN-O by Ampcor, Inc. — Product Code GTQ

K890025 is an FDA 510(k) premarket notification submitted by Ampcor, Inc. for the device "QUIK-DOT ANTISTREPTOLYSIN-O". The FDA issued a decision of Substantially Equivalent on January 31, 1989. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Ampcor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1989
Date Received
January 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antistreptolysin - Titer/Streptolysin O Reagent
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
Submission Type

Other clearances by Ampcor, Inc.

  • K922297 — INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST (July 14, 1992)
  • K922296 — IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST (July 14, 1992)
  • K910438 — DIPSTICK SALMONELLA (September 13, 1991)
  • K893873 — SINGLE AND DUAL BAND DIPSTICK HCG TEST (August 21, 1989)
  • K890048 — QUIK-DOT TOXOPLASMOSIS (June 9, 1989)
  • K892146 — C REACTIVE PROTEIN LIQUID (April 14, 1989)
  • K892119 — QUIK-DOT C REACTIVE PROTEIN (April 14, 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 GTQ

  • K052645 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PROD (December 14, 2005)
  • K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT (October 20, 1995)
  • K915742 — TURBIQUANT ASL (June 28, 1993)
  • K926236 — BECKMAN ANTI-STREPTOLYSIN O KIT (June 15, 1993)
  • K924247 — ACCUTEX ASO LATEX TEST (December 7, 1992)
  • K922723 — TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (September 18, 1992)
  • K915053 — BECKMAN ANTISTREPTOLYSIN O, MODIFICATION (March 19, 1992)
  • K912150 — BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (July 17, 1991)
  • K904416 — CROATEST (R) RHEUMATOID DIAGNOSTIC (June 24, 1991)
  • K910885 — QM300 CALIBRATOR G PACK (June 17, 1991)

FDA data resources