510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN140044Unknown

23Andme Personal Genome Service (Hereinafter Known as Pgs)

23AndMe, Inc., Mountain View CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN140044 is the FDA 510(k) clearance record for 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS), a class II device, cleared for 23AndMe on under FDA product code PKB (Autosomal Recessive Carrier Screening Gene Mutation Detection System). FDA's definition for product code PKB reads: "Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or...". FDA records list 9 510(k) clearances for 23AndMe, from to . As of , FDA records show no recalls naming DEN140044.

Clearance record

Decision date
Received
(266 days to decision)
Product code
PKB Autosomal Recessive Carrier Screening Gene Mutation Detection System
Regulation
21 CFR 866.5940
Device class
Class II
Review panel
Immunology
Applicant
23AndMe 1390 Shorebird Way, Mountain View CA
Third party review
No

Clearances, product code PKB

Trailing 12 months

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

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