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510(k) K821347

BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. by Bioclinical Corp. — Product Code LCA

K821347 is an FDA 510(k) premarket notification submitted by Bioclinical Corp. for the device "BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.". The FDA issued a decision of Substantially Equivalent on May 28, 1982. The device falls under product code LCA (Radioimmunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1982
Date Received
May 5, 1982
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

Other clearances for product code LCA

  • K880291 — THEOPHYLLINE TEST KIT REF. #A874799 (March 24, 1988)
  • K833789 — PHASE II THEOPHYLLINE RADIOIMMUNOASSAY (January 24, 1984)
  • K821862 — QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. (July 6, 1982)
  • K792062 — THEOPHYLLINE RIASSAY (February 25, 1980)

FDA data resources