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510(k) K971817

OLYMPUS CK-MB REAGENT by Olympus America, Inc. — Product Code JLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1997
Date Received
May 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Atp And Creatine Kinase (Enzymatic), Creatine
Device Class
Class I
Regulation Number
862.1210
Review Panel
CH
Submission Type

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Other clearances for product code JLB

  • K992140 — PICCOLO METLYTE 7 REAGENT DISC (August 26, 1999)
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