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510(k) K884940

RELLPLATE C KIT, RELLPLATE C BULK PLATES by American Diagnostic Corp. — Product Code GGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1989
Date Received
November 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

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  • K893608 — ACTICHROME ATIII KIT (June 23, 1989)

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