510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011528Substantially Equivalent

Emit 2000 Phenobarbital Assay, Model Osr4d229

Syva Co., San Jose CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K011528 is the FDA 510(k) clearance record for EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229, a class II device, cleared for Syva Co. on under FDA product code DLZ (Enzyme Immunoassay, Phenobarbital). FDA records list 59 510(k) clearances for Syva Co., from to . As of , FDA records show 3 recalls naming K011528.

Clearance record

Decision date
Received
(20 days to decision)
Product code
DLZ Enzyme Immunoassay, Phenobarbital
Regulation
21 CFR 862.3660
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Syva Co. 3403 Yerba Buena Rd., San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code DLZ

Trailing 12 months

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

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