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510(k) K822115

SERAGAN ACTH125 I-RIA KIT by Seragen Diagnostics, Inc. — Product Code CKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1982
Date Received
July 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Acth
Device Class
Class II
Regulation Number
862.1025
Review Panel
CH
Submission Type

Other clearances by Seragen Diagnostics, Inc.

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  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 1985)
  • K850209 — QUICK-LYTE (February 27, 1985)
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  • K842563 — SERATEST DNA DETERMINATION (October 25, 1984)
  • K841504 — QUICK-COUNT PLUS 2 (June 11, 1984)
  • K840793 — CK/MB IMMUNO-ISOENZYME CONTROL SERUM (April 13, 1984)

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