510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924074Substantially Equivalent

Stratus Vitamin B12 Fluorometric Enzyme-Linked

Baxter Diagnostics, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924074 is the FDA 510(k) clearance record for STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED, a class II device, cleared for Baxter Diagnostics, Inc. on under FDA product code CDD (Radioassay, Vitamin B12). FDA records list 72 510(k) clearances for Baxter Diagnostics, Inc., from to . As of , FDA records show no recalls naming K924074.

Clearance record

Decision date
Received
(75 days to decision)
Product code
CDD Radioassay, Vitamin B12
Regulation
21 CFR 862.1810
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Baxter Diagnostics, Inc. P.O.Box 520672, Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code CDD

Trailing 12 months

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

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