510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850739Substantially Equivalent

Amendment to Labeling Microtrak Hsv 1/Hsv 2 Direct

Syva Co., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850739 is the FDA 510(k) clearance record for AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT, a class II device, cleared for Syva Co. on under FDA product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2). FDA records list 140 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K850739.

Clearance record

Decision date
Received
(24 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
Syva Co. 900 Arastradero Rd., Palo Alto 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