Device Type ID | 419 |
Device Name | Colorimetric Method, Lipoproteins |
Regulation Description | Lipoprotein 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 | 862.1475 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | JHM |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 419 |
Device | Colorimetric Method, Lipoproteins |
Product Code | JHM |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Lipoprotein Test System. |
CFR Regulation Number | 862.1475 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Siemens Healthcare Diagnostics, Inc. | II | May-11-2016 |