510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K874702Substantially Equivalent

Revised Labeling for Syva Barbiturate Assays

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

K874702 is the FDA 510(k) clearance record for REVISED LABELING FOR SYVA BARBITURATE ASSAYS, a class II device, cleared for Syva Co. on under FDA product code DIS (Enzyme Immunoassay, Barbiturate). FDA records list 140 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K874702.

Clearance record

Decision date
Received
(50 days to decision)
Product code
DIS Enzyme Immunoassay, Barbiturate
Regulation
21 CFR 862.3150
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Syva Co. 900 Arastradero Rd., Palo Alto CA
Third party review
No

Clearances, product code DIS

Trailing 12 months

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

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