510(k) K792696
K792696 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "MICROPITETTE". The FDA issued a decision of Substantially Equivalent on February 1, 1980. The device falls under product code JRC (Micro Pipette), a Class I device regulated under 21 CFR 862.2050. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1980
- Date Received
- December 27, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Micro Pipette
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type