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
K895648Substantially Equivalent

Coated Tube High Sensitivity Tsh 100 Uiu/ml Stan.

Ventrex Laboratories, Inc., Portland ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895648 is the FDA 510(k) clearance record for COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN., a class II device, cleared for Ventrex Laboratories, Inc. on under FDA product code JIT (Calibrator, Secondary). FDA records list 82 510(k) clearances for Ventrex Laboratories, Inc., from to . As of , FDA records show no recalls naming K895648.

Clearance record

Decision date
Received
(120 days to decision)
Product code
JIT Calibrator, Secondary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ventrex Laboratories, Inc. 217 Read St., Portland ME
Third party review
No

Clearances, product code JIT

Trailing 12 months

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

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