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510(k) K002128

ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 by Diagnostic Systems Laboratories, Inc. — Product Code NDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2000
Date Received
July 14, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Inhibin-A
Device Class
Class I
Regulation Number
862.1260
Review Panel
CH
Submission Type

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