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510(k) K880291

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

K880291 is an FDA 510(k) premarket notification submitted by Photec Diagnostics, Inc. for the device "THEOPHYLLINE TEST KIT REF. #A874799". The FDA issued a decision of Substantially Equivalent on March 24, 1988. The device falls under product code LCA (Radioimmunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Photec Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Photec Diagnostics, Inc.

  • K897169 — QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT (February 23, 1990)
  • K896329 — D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. (December 12, 1989)
  • K894057 — QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT (August 31, 1989)
  • K892224 — D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN (June 16, 1989)
  • K890267 — QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA (April 26, 1989)
  • K890027 — QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD (April 26, 1989)
  • K882307 — D-CHEM (August 2, 1988)
  • K854875 — APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 (January 24, 1986)
  • K853048 — APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 (August 28, 1985)
  • K853174 — APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN (August 22, 1985)

Other clearances for product code LCA

  • 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)
  • K792062 — THEOPHYLLINE RIASSAY (February 25, 1980)

FDA data resources