510(k) K892329
K892329 is an FDA 510(k) premarket notification submitted by D.R.G. Scientific Industries for the device "OSMOMETER STANDARD SOLUTIONS". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. D.R.G. Scientific Industries has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1989
- Date Received
- April 5, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Secondary
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type