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510(k) K810870

GEMENI CK-MB ISOENZYME ABNORMAL SERUM by Gemini, Inc. — Product Code JJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1981
Date Received
March 31, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Gemini, Inc.

  • K810534 — GEMENI QUICK-MB SEPARATION KIT (March 11, 1981)

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