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510(k) K782070

REAGENT, COCCI LATEX by I M, Inc. — Product Code GMG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1979
Date Received
December 12, 1978
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

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Other clearances for product code GMG

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  • K791381 — COCCIDIODES (COCCI) (August 16, 1979)
  • K760829 — COCCIDIOIDES MYCELIAL ANTIGEN (November 1, 1976)