510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935568Substantially Equivalent

Paramax Phenobarbital Reagent and Calibrators

Baxter Diagnostics, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935568 is the FDA 510(k) clearance record for PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS, a class II device, cleared for Baxter Diagnostics, Inc. on under FDA product code DLZ (Enzyme Immunoassay, Phenobarbital). FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K935568.

Clearance record

Decision date
Received
(113 days to decision)
Product code
DLZ Enzyme Immunoassay, Phenobarbital
Regulation
21 CFR 862.3660
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Baxter Diagnostics, Inc. P.O. Box 25101, Santa Ana 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