510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880291Substantially Equivalent

Theophylline Test Kit Ref. #A874799

Photec Diagnostics, Inc., Little Falls NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880291 is the FDA 510(k) clearance record for THEOPHYLLINE TEST KIT REF. #A874799, a class II device, cleared for Photec Diagnostics, Inc. on under FDA product code LCA (Radioimmunoassay, Theophylline). FDA records list 12 510(k) clearances for Photec Diagnostics, Inc., from to . As of , FDA records show no recalls naming K880291.

Clearance record

Decision date
Received
(59 days to decision)
Product code
LCA Radioimmunoassay, Theophylline
Regulation
21 CFR 862.3880
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Photec Diagnostics, Inc. 101 E. Main St., Little Falls NJ
Third party review
No

Clearances, product code LCA

Trailing 12 months

FDA records hold no clearances under product code LCA in the trailing twelve months.

FDA records show no clearances under product code LCA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260