510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K855026Substantially Equivalent

Acculevel Phenytoin Test

Syva / A Syntex Co., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855026 is the FDA 510(k) clearance record for ACCULEVEL PHENYTOIN TEST, a class II device, cleared for Syva / A Syntex Co. on under FDA product code DIP (Enzyme Immunoassay, Diphenylhydantoin). FDA records list 2 510(k) clearances for Syva / A Syntex Co., from to . As of , FDA records show no recalls naming K855026.

Clearance record

Decision date
Received
(252 days to decision)
Product code
DIP Enzyme Immunoassay, Diphenylhydantoin
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Syva / A Syntex Co. 900 Arastradero Rd., Palo Alto CA
Third party review
No

Clearances, product code DIP

Trailing 12 months

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

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