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510(k) K932657

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 by More Diagnostics — Product Code DAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1993
Date Received
June 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

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  • K943571 — MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS (June 15, 1995)
  • K944999 — SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 (June 6, 1995)
  • K941698 — SERUM VOLATILES CONTROL - LEVELS 1 AND 2 (July 28, 1994)

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