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510(k) K880291

THEOPHYLLINE TEST KIT REF. #A874799 by Photec Diagnostics, Inc. — Product Code LCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
January 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
Submission Type

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Other clearances for product code LCA

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  • K821347 — BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. (May 28, 1982)
  • K792062 — THEOPHYLLINE RIASSAY (February 25, 1980)