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
K921616Substantially Equivalent for Some Indications

Cmv-Vue(tm) Cmv Antigen Detection Kit

Incstar Corp., Stillwater MN / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K921616 is the FDA 510(k) clearance record for CMV-VUE(TM) CMV ANTIGEN DETECTION KIT, a class II device, cleared for Incstar Corp. on under FDA product code LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus). FDA records list 58 510(k) clearances for Incstar Corp., from to . As of , FDA records show no recalls naming K921616.

Clearance record

Decision date
Received
(127 days to decision)
Product code
LIN Antisera, Conjugated Fluorescent, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Incstar Corp. 1990 Insustrial Blvd., Stillwater MN
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