510(k) K842750
K842750 is an FDA 510(k) premarket notification submitted by Kyoto Diagnostics, Inc. for the device "OSMOTIC PRESSURE AUTO & STAT OM-6010". The FDA issued a decision of Substantially Equivalent on August 17, 1984. The device falls under product code JJM (Osmometer For Clinical Use), a Class I device regulated under 21 CFR 862.2730. Kyoto Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1984
- Date Received
- July 13, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Osmometer For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2730
- Review Panel
- CH
- Submission Type