510(k) K770745
K770745 is an FDA 510(k) premarket notification submitted by Micro-Media Systems, Inc. for the device "PANEL, GNF, MICRO-ID". The FDA issued a decision of Substantially Equivalent on June 23, 1977. The device falls under product code JSW (Kit, Identification, Glucose Nonfermenter), a Class I device regulated under 21 CFR 866.2660. Micro-Media Systems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1977
- Date Received
- April 22, 1977
- 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