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510(k) K792062

THEOPHYLLINE RIASSAY by Ria Diagnostics — Product Code LCA

K792062 is an FDA 510(k) premarket notification submitted by Ria Diagnostics for the device "THEOPHYLLINE RIASSAY". The FDA issued a decision of Substantially Equivalent on February 25, 1980. The device falls under product code LCA (Radioimmunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Ria Diagnostics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1980
Date Received
October 15, 1979
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 by Ria Diagnostics

  • K855033 — T-3 UPTAKE/RIASSAY (January 24, 1986)
  • K854798 — T-4 RIASSAY (January 15, 1986)
  • K852537 — T-3 RIASSAY (August 12, 1985)
  • K810296 — DIGOXIN RIA ASSAY (February 19, 1981)
  • K801691 — TSH RIASSAY (August 27, 1980)
  • K780012 — ANTITHROMBIN III RIA (January 20, 1978)

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)
  • K821347 — BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. (May 28, 1982)

FDA data resources