510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955362Substantially Equivalent

Incstar Hsv i/ii Igg Fast Elisa Assay

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

K955362 is the FDA 510(k) clearance record for INCSTAR HSV I/II IGG FAST ELISA ASSAY, a class I device, cleared for Incstar Corp. on under FDA product code IGC (Formalin-Saline). FDA records list 58 510(k) clearances for Incstar Corp., from to . As of , FDA records show no recalls naming K955362.

Clearance record

Decision date
Received
(245 days to decision)
Product code
IGC Formalin-Saline
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Incstar Corp. 1990 Industrial Blvd., Stillwater MN
510(k) summary
Summary
Third party review
No

Clearances, product code IGC

Trailing 12 months

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

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