510(k) K823535
- Device
- DILUENT, ZEROING SOLUTION & CO-OX/ISE
- Applicant
- SHABAN MFG. CO.
- 510(k) number
- K823535
- Product code
- JKT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-28
- Date received
- 1982-11-30
- Regulation
- 862.3220
- Classification name
- Gas Chromatograph, Carbon-monoxide
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- MD US
FDA Registration Numbers#
- 3043088937
- 3043138885
- 3027645317
- 1223858
- 3009896423
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JKT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K830843 | BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- | Rna Medical Corp. | 1983-04-28 |
Legacy Summary#
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FDA Review#
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