DILUENT, ZEROING SOLUTION & CO-OX/ISE
FDA 510(k) clearance K823535 · decided 1983-01-28
Clearance details
- K-number
- K823535
- Device name
- DILUENT, ZEROING SOLUTION & CO-OX/ISE
- Applicant
- Shaban Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-30
- Decision date
- 1983-01-28
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- JKT
- Device class
- 1
- Regulation number
- 862.3220
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- MD, 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 |
|---|---|---|
| BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- (K830843) | Rna Medical Corp. | 1983-04-28 |
Recalls involving this device
No recalls on record reference this clearance.