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510(k) K831628

CREATININE REAGENTS B6370-13 by American Scientific Products — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1983
Date Received
May 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
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)
  • 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)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K831571 — ROTOR (June 30, 1983)
  • K822799 — STREPTACOCCUS CO-AGGLUTINATION KIT (December 19, 1982)

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