510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854712Substantially Equivalent

Visible-Herpes Tm Test System

Isolab, Inc., Akron OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854712 is the FDA 510(k) clearance record for VISIBLE-HERPES TM TEST SYSTEM, a class II device, cleared for Isolab, Inc. on under FDA product code GQO (Antisera, Cf, Herpesvirus Hominis 1,2). FDA records list 44 510(k) clearances for Isolab, Inc., from to . As of , FDA records show no recalls naming K854712.

Clearance record

Decision date
Received
(179 days to decision)
Product code
GQO Antisera, Cf, Herpesvirus Hominis 1,2
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Isolab, Inc. Drawer 4350, Akron OH
Third party review
No

Clearances, product code GQO

Trailing 12 months

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

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