510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193492Substantially Equivalent

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

23AndMe, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193492 is the FDA 510(k) clearance record for 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports, a class II device, cleared for 23AndMe, Inc. on under FDA product code QDJ (Direct-To-Consumer Access Pharmacogenetic Assessment System). FDA's definition for product code QDJ reads: "A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic...". FDA records list 9 510(k) clearances for 23AndMe, Inc., from to . As of , FDA records show no recalls naming K193492.

Clearance record

Decision date
Received
(244 days to decision)
Product code
QDJ Direct-To-Consumer Access Pharmacogenetic Assessment System
Regulation
21 CFR 862.3364
Device class
Class II
Review panel
Medical Genetics
Applicant
23AndMe, Inc. 223 N Mathilda Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDJ

Trailing 12 months

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

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