510(k) K843680
K843680 is an FDA 510(k) premarket notification submitted by Cenogenics Corp. for the device "URI-VAL". The FDA issued a decision of Substantially Equivalent on March 29, 1985. The device falls under product code JMZ (Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality), a Class I device regulated under 21 CFR 862.1540. Cenogenics Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 1985
- Date Received
- September 18, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
- Device Class
- Class I
- Regulation Number
- 862.1540
- Review Panel
- CH
- Submission Type