510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894527Substantially Equivalent

Fpr Phenytoin Kit

Colony Laboratories, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894527 is the FDA 510(k) clearance record for FPR PHENYTOIN KIT, a class II device, cleared for Colony Laboratories, Inc. on under FDA product code DLP (Radioimmunoassay, Diphenylhydantoin). FDA records list 16 510(k) clearances for Colony Laboratories, Inc., from to . As of , FDA records show no recalls naming K894527.

Clearance record

Decision date
Received
(67 days to decision)
Product code
DLP Radioimmunoassay, Diphenylhydantoin
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Colony Laboratories, Inc. 1220 Nineteenth St., NW, Washington DC
Third party review
No

Clearances, product code DLP

Trailing 12 months

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

FDA records show no clearances under product code DLP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DLP, 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