510(k) K771617
K771617 is an FDA 510(k) premarket notification submitted by Thermolyne Corp. for the device "SPECI-MIX". The FDA issued a decision of Substantially Equivalent on September 2, 1977. The device falls under product code GLE (Mixer, Blood Tube), a Class I device regulated under 21 CFR 862.2050. Thermolyne Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 1977
- Date Received
- August 24, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mixer, Blood Tube
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type