510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K955873Substantially Equivalent

Acs Phenytoin Assay

Ciba Corning Diagnostics Corp., Medfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955873 is the FDA 510(k) clearance record for ACS PHENYTOIN ASSAY, a class II device, cleared for Ciba Corning Diagnostics Corp. on under FDA product code LGR (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)). FDA records list 125 510(k) clearances for Ciba Corning Diagnostics Corp., from to . As of , FDA records show no recalls naming K955873.

Clearance record

Decision date
Received
(76 days to decision)
Product code
LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Ciba Corning Diagnostics Corp. 63 N. St., Medfield MA
510(k) summary
Summary
Third party review
No

Clearances, product code LGR

Trailing 12 months

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

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