510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143236Substantially Equivalent

Theranos Herpes Simplex Virus-1 IgG Assay

Theranos, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143236 is the FDA 510(k) clearance record for Theranos Herpes Simplex Virus-1 IgG Assay, a class II device, cleared for Theranos, Inc. on under FDA product code MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1). FDA records list one 510(k) clearance for Theranos, Inc. As of , FDA records show no recalls naming K143236.

Clearance record

Decision date
Received
(232 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
Theranos, Inc. 1701 Page Mill Rd., Palo Alto 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