FDA Browser
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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
Miscellaneous
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Clinical Toxicology Test Systems
CFR Sub-Part
QDJ
Direct-To-Consumer Access Pharmacogenetic Assessment System
2
Product Code
K
22
1885
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
2
Cleared 510(K)
K
19
3492
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
2
Cleared 510(K)
DEN
18
0028
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
2
Cleared 510(K)
MXA
System, Test, Breath Nitric Oxide
2
Product Code
OIC
Blood Alcohol Kit (Excludes Hiv Testing)
2
Product Code
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
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Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
CH
/
subpart-d—clinical-toxicology-test-systems
/
QDJ
/
K193492
View Source
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Miscellaneous
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Clinical Toxicology Test Systems
QDJ
Direct-To-Consumer Access Pharmacogenetic Assessment System
K
22
1885
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
K
19
3492
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
DEN
18
0028
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
MXA
System, Test, Breath Nitric Oxide
OIC
Blood Alcohol Kit (Excludes Hiv Testing)
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Serological Reagents
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Immunological Test Systems
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CH
/
subpart-d—clinical-toxicology-test-systems
/
QDJ
/
K193492
View Source
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...