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510(k) K822799

STREPTACOCCUS CO-AGGLUTINATION KIT by American Scientific Products — Product Code GTP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1982
Date Received
September 16, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exoenzymes, Multiple, Streptococcal
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
Submission Type

Other clearances by American Scientific Products

  • K864824 — INFECTIOUS TISSUE KIT (December 24, 1986)
  • K844042 — BLOOD DILUTION VIAL (October 23, 1984)
  • K831634 — GLUCOSE REAGENT B6360-11 (July 19, 1983)
  • K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A (July 7, 1983)
  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K831571 — ROTOR (June 30, 1983)

Other clearances for product code GTP

  • K860041 — STREP D FLUOR (January 24, 1986)
  • K833738 — LEAP STREP TEST KIT (December 27, 1983)