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
K051714Substantially Equivalent

Total Bile Acids Assay, Model Dz042a

Diazyme Laboratories, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051714 is the FDA 510(k) clearance record for TOTAL BILE ACIDS ASSAY, MODEL DZ042A, a class II device, cleared for Diazyme Laboratories on under FDA product code KWW (Radioimmunoassay, Cholyglycine, Bile Acids). FDA records list 52 510(k) clearances for Diazyme Laboratories, from to . As of , FDA records show no recalls naming K051714.

Clearance record

Decision date
Received
(163 days to decision)
Product code
KWW Radioimmunoassay, Cholyglycine, Bile Acids
Regulation
21 CFR 862.1177
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diazyme Laboratories 3550 General Atomics Ct., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWW

Trailing 12 months

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

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