510(k) K780544
K780544 is an FDA 510(k) premarket notification submitted by Techhnilab Instruments, Inc. for the device "DISC-PAK ROTATOR". The FDA issued a decision of Substantially Equivalent on April 24, 1978. The device falls under product code GLE (Mixer, Blood Tube), a Class I device regulated under 21 CFR 862.2050. Techhnilab Instruments, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 1978
- Date Received
- April 3, 1978
- 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