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510(k) K884750

GROUP A STREP, BETA-STREP by Ampcor, Inc. — Product Code GTZ

K884750 is an FDA 510(k) premarket notification submitted by Ampcor, Inc. for the device "GROUP A STREP, BETA-STREP". The FDA issued a decision of Substantially Equivalent on December 22, 1988. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Ampcor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1988
Date Received
November 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
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)
  • K890025 — QUIK-DOT ANTISTREPTOLYSIN-O (January 31, 1989)
  • K880163 — PREGNANCY (HCG) CARD & LIQUID TEST (May 17, 1988)
  • K880478 — PREGNANCY BETA-HCG CARD & LIQUID TEST (April 28, 1988)

Other clearances for product code GTZ

  • K012521 — BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST (November 30, 2001)
  • K011709 — UNI-GOLD STREP A TEST KIT (November 8, 2001)
  • K010523 — MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (March 15, 2001)
  • K991726 — BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST (August 27, 1999)
  • K971522 — ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II (March 3, 1998)
  • K962060 — STREP A OIA MAX (July 23, 1997)
  • K962296 — STREPTOLEX-STAT (December 16, 1996)
  • K961423 — OSOM STREP A TEST (October 11, 1996)
  • K962146 — EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT (October 7, 1996)
  • K955108 — CARDS Q.S. STREP A (April 15, 1996)

FDA data resources