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510(k) K810534

GEMENI QUICK-MB SEPARATION KIT by Gemini, Inc. — Product Code JHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1981
Date Received
February 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic Separation, Cpk Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Gemini, Inc.

  • K810870 — GEMENI CK-MB ISOENZYME ABNORMAL SERUM (April 14, 1981)

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