CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
FDA 510(k) clearance K192730 · decided 2020-09-09
Clearance details
- K-number
- K192730
- Device name
- CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
- Applicant
- Biosystems S.A.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-27
- Decision date
- 2020-09-09
- Days to decision
- 348 days
- Clearance type
- Traditional
- Product code
- CHW
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Barcelona, ES
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CALCIUM GEN. 2 (K113521) | Roche Diagnostics | 2012-05-08 |
| LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA (K781454) | Union Carbide Corp. | 1978-09-20 |
Recalls involving this device
No recalls on record reference this clearance.