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510(k) K872360

DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET by American Dade — Product Code GHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1987
Date Received
June 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrin Split Products
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

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  • K871972 — STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (July 21, 1987)
  • K871977 — DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (July 9, 1987)
  • K872050 — PARAMAX CHOLESTEROL REAGENT (July 7, 1987)
  • K870158 — STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. (March 19, 1987)

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