510(k) K770165
K770165 is an FDA 510(k) premarket notification submitted by Maddak, Inc. for the device "MICRO-MIX PIPETTE SHAKER". The FDA issued a decision of Substantially Equivalent on January 31, 1977. The device falls under product code JRQ (Shaker/Stirrer), a Class I device regulated under 21 CFR 862.2050. Maddak, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1977
- Date Received
- January 25, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shaker/Stirrer
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type