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510(k) K910438

DIPSTICK SALMONELLA by Ampcor, Inc. — Product Code GRM

K910438 is an FDA 510(k) premarket notification submitted by Ampcor, Inc. for the device "DIPSTICK SALMONELLA". The FDA issued a decision of Substantially Equivalent on September 13, 1991. The device falls under product code GRM (Antisera, All Groups, Salmonella Spp.), a Class II device regulated under 21 CFR 866.3550. Ampcor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1991
Date Received
January 31, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Groups, Salmonella Spp.
Device Class
Class II
Regulation Number
866.3550
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)
  • 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)
  • 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 GRM

  • K961951 — SAS SALMONELLA O FACTOR 6 ANTISERUM (June 18, 1996)
  • K961958 — SAS SALMONELLA H Z4 COMPLEX ANTISERUM (June 18, 1996)
  • K961956 — SAS SALMONELLA H G,M,Q ANTISERMU (June 18, 1996)
  • K961961 — SAS SALMONELLA H F,G,T ANTISERUM (June 18, 1996)
  • K961953 — SAS SALMONELA H Z24 ANTISERUM (June 18, 1996)
  • K961954 — SAS SALMONELLA H Z35 ANTISERUM (June 18, 1996)
  • K961960 — SAS SALMONELLA H Z4, Z24 ANTISERUM (June 18, 1996)
  • K961964 — SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM (June 18, 1996)
  • K961963 — SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM (June 18, 1996)
  • K961949 — SAS SALMONELLA O FACTOR 14 ANTISERUM (June 18, 1996)

FDA data resources