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510(k) K844042

BLOOD DILUTION VIAL by American Scientific Products — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1984
Date Received
October 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Cell, Automated (Particle Counter)
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

Other clearances by American Scientific Products

  • K864824 — INFECTIOUS TISSUE KIT (December 24, 1986)
  • 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)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831571 — ROTOR (June 30, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K822799 — STREPTACOCCUS CO-AGGLUTINATION KIT (December 19, 1982)

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