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510(k) K831626

UREA NITROGEN-BUN-REAGENTS B6370-11A by American Scientific Products — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
May 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by American Scientific Products

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  • 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)
  • K822799 — STREPTACOCCUS CO-AGGLUTINATION KIT (December 19, 1982)

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