510(k) K850725
K850725 is an FDA 510(k) premarket notification submitted by Microtech Medical Systems, Inc. for the device "QUADRA TITER MICRO PLATES". The FDA issued a decision of Substantially Equivalent on April 30, 1985. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Microtech Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 1985
- Date Received
- February 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, General Purpose, Microbiology, Diagnostic
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type