MODEL 90 BC
FDA 510(k) clearance K821415 · decided 1982-05-27
Clearance details
- K-number
- K821415
- Device name
- MODEL 90 BC
- Applicant
- Western Laboratories Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-12
- Decision date
- 1982-05-27
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- FLB
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- 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 |
|---|---|---|
| DIALYSATE METER, MODEL D-6 (K100237) | Myron L Company | 2010-04-23 |
| 90DX MULTITEST METER, MODIFICATION (K925210) | Mesa Medical, Inc. | 1994-01-25 |
| MODEL 90DX MULTITEST METER (K882032) | Mesa Medical, Inc. | 1988-08-11 |
| COBE RX METER (K830629) | Cobe Laboratories, Inc. | 1983-04-06 |
| DIALYSATE METER RS-2100A, CIRCUIT CHANGE (K770263) | Renal Systems, Inc. | 1977-02-18 |
Recalls involving this device
No recalls on record reference this clearance.