BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-
FDA 510(k) clearance K830843 · decided 1983-04-28
Clearance details
- K-number
- K830843
- Device name
- BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-
- Applicant
- Rna Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-17
- Decision date
- 1983-04-28
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- JKT
- Device class
- 1
- Regulation number
- 862.3220
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| DILUENT, ZEROING SOLUTION & CO-OX/ISE (K823535) | Shaban Mfg. Co. | 1983-01-28 |
Recalls involving this device
No recalls on record reference this clearance.