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510(k) K812189

COCCIDIOIDES LATEX AGGLUTINATION by American Scientific Products — Product Code GMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1981
Date Received
August 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Latex Agglutination, Coccidioides Immitis
Device Class
Class II
Regulation Number
866.3135
Review Panel
MI
Submission Type

Other clearances by American Scientific Products

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  • 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)
  • 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)
  • K831571 — ROTOR (June 30, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)

Other clearances for product code GMG

  • K792690 — COCCIDIOIDES IMMITIS, LATEX AGGLUTI (January 17, 1980)
  • K791381 — COCCIDIODES (COCCI) (August 16, 1979)
  • K782070 — REAGENT, COCCI LATEX (February 1, 1979)
  • K760829 — COCCIDIOIDES MYCELIAL ANTIGEN (November 1, 1976)