510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131334Substantially Equivalent

Herpes Simplex Virus Type 1 Igg Elisa Test

Gold Standard Diagnostics, LLC, Davis CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131334 is the FDA 510(k) clearance record for HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST, a class II device, cleared for Gold Standard Diagnostics on under FDA product code MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1). FDA records list 15 510(k) clearances for Gold Standard Diagnostics, from to . As of , FDA records show no recalls naming K131334.

Clearance record

Decision date
Received
(295 days to decision)
Product code
MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Gold Standard Diagnostics 2851 Spafford St., Davis CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXJ

Trailing 12 months

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

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