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510(k) K864824

INFECTIOUS TISSUE KIT by American Scientific Products

K864824 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "INFECTIOUS TISSUE KIT". The FDA issued a decision of Substantially Equivalent on December 24, 1986. American Scientific Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1986
Date Received
December 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by American Scientific Products

  • K844042 — BLOOD DILUTION VIAL (October 23, 1984)
  • K831634 — GLUCOSE REAGENT B6360-11 (July 19, 1983)
  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A (July 7, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K831571 — ROTOR (June 30, 1983)
  • K822799 — STREPTACOCCUS CO-AGGLUTINATION KIT (December 19, 1982)

FDA data resources