510(k) K843680
- Device
- URI-VAL
- Applicant
- CENOGENICS CORP.
- 510(k) number
- K843680
- Product code
- JMZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-29
- Date received
- 1984-09-18
- Regulation
- 862.1540
- Classification name
- Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL KATZ
- Address
- 620 Rte. 520 Morganville NJ US 07751 07751
FDA Registration Numbers#
- 3003393069
- 1217058
- 1717966
- 3009155756
- 3013545943
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JMZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K844589 | OSMOLARITY STANDARDS | Rna Medical Corp. | 1985-03-01 |
Legacy Summary#
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FDA Review#
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