510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K161721Substantially Equivalent

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set

Diazyme Laboratories, Inc., Poway CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K161721 is the FDA 510(k) clearance record for Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set, a class II device, cleared for Diazyme Laboratories on under FDA product code CDD (Radioassay, Vitamin B12). FDA records list 52 510(k) clearances for Diazyme Laboratories, from to . As of , FDA records show no recalls naming K161721.

Clearance record

Decision date
Received
(90 days to decision)
Product code
CDD Radioassay, Vitamin B12
Regulation
21 CFR 862.1810
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diazyme Laboratories 12889 Gregg Ct., Poway CA
510(k) summary
Statement
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