Device Type ID | 606 |
Device Name | Acid, Uric, Acid Reduction Of Ferric Ion |
Regulation Description | Uric Acid 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) Exempt |
CFR Regulation Number | 862.1775 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | LFQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 606 |
Device | Acid, Uric, Acid Reduction Of Ferric Ion |
Product Code | LFQ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Uric Acid Test System. |
CFR Regulation Number | 862.1775 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Sterling Diagnostics, Inc. | III | Dec-29-2016 |