| Device Type ID | 468 |
| Device Name | Urinalysis Controls (assayed And Unassayed) |
| Regulation Description | Quality Control Material (assayed And Unassayed). |
| 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 | 862.1660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JJW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 468 |
| Device | Urinalysis Controls (assayed And Unassayed) |
| Product Code | JJW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Quality Control Material (assayed And Unassayed). |
| CFR Regulation Number | 862.1660 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
QUANTIMETRIX CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRECK | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Loose Or Intermittent Connection | 1 |
Migration | 1 |
Loss Of Or Failure To Bond | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Lin-Zhi International Inc | II | Mar-12-2014 |
| 2 | Quantimetrix Corporation | III | Jun-20-2018 |