Device Type ID | 429 |
Device Name | Enzymatic Methods, Galactose |
Regulation Description | Galactose Test System. |
Regulation Medical Specialty | Clinical Chemistry |
Review Panel | Clinical Chemistry |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 862.1310 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | JIA |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 429 |
Device | Enzymatic Methods, Galactose |
Product Code | JIA |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Galactose Test System. |
CFR Regulation Number | 862.1310 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |