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
K034000Substantially Equivalent

Vitalab Triglycerides Reagent and Vitalab Calibrator

Clinical Data, Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K034000 is the FDA 510(k) clearance record for VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR, a class I device, cleared for Clinical Data, Inc. on under FDA product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides). FDA records list 37 510(k) clearances for Clinical Data, Inc., from to . As of , FDA records show no recalls naming K034000.

Clearance record

Decision date
Received
(77 days to decision)
Product code
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Regulation
21 CFR 862.1705
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Clinical Data, Inc. 1075 W. Lambert Rd., Brea CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code CDT

Trailing 12 months

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

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