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510(k) K831434

ISO-SEP SYSTEM by Berwick Medical Products, Inc. — Product Code CDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
May 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Triiodothyronine
Device Class
Class II
Regulation Number
862.1710
Review Panel
CH
Submission Type

Other clearances by Berwick Medical Products, Inc.

  • K850800 — DROPSTIRS - PLASTIC DISPOSABLE PIPET (April 2, 1985)
  • K842018 — ISO-SEP SYSTEM (September 28, 1984)
  • K831289 — PREFILLED IEC COLUMNS (June 16, 1983)
  • K830918 — I.E.C COLUMN (April 27, 1983)

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