510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870814Substantially Equivalent

Herpes Simplex Antibody Test for Dect. of Hsv 1&2

Microscan Div. Baxter Healthcare Corp., West Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870814 is the FDA 510(k) clearance record for HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2, a class II device, cleared for Microscan Div. Baxter Healthcare Corp. on under FDA product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2). FDA records list 11 510(k) clearances for Microscan Div. Baxter Healthcare Corp., from to . As of , FDA records show no recalls naming K870814.

Clearance record

Decision date
Received
(93 days to decision)
Product code
GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Microscan Div. Baxter Healthcare Corp. 2040 Enterprise Blvd., West Sacramento CA
Third party review
No

Clearances, product code GQL

Trailing 12 months

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

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