510(k) K813640
K813640 is an FDA 510(k) premarket notification submitted by Dynatech Corp. for the device "MINIWASH II". The FDA issued a decision of Substantially Equivalent on January 28, 1982. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Dynatech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1982
- Date Received
- December 31, 1981
- 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