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
K951550Substantially Equivalent

Cmv Brite Antigenemia Test Kit

Biotest Diagnostics Corp., Denville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951550 is the FDA 510(k) clearance record for CMV BRITE ANTIGENEMIA TEST KIT, a class II device, cleared for Biotest Diagnostics Corp. on under FDA product code LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus). FDA records list 5 510(k) clearances for Biotest Diagnostics Corp., from to . As of , FDA records show no recalls naming K951550.

Clearance record

Decision date
Received
(301 days to decision)
Product code
LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Biotest Diagnostics Corp. 66 Ford Rd., Suite 131, Denville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LIN

Trailing 12 months

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

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