510(k) K790992
K790992 is an FDA 510(k) premarket notification submitted by Micro-Palettes, Inc. for the device "PSEUDO-PALETTE TM". The FDA issued a decision of Substantially Equivalent on June 22, 1979. The device falls under product code JSW (Kit, Identification, Glucose Nonfermenter), a Class I device regulated under 21 CFR 866.2660. Micro-Palettes, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1979
- Date Received
- May 29, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Identification, Glucose Nonfermenter
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type