510(k) K760743
K760743 is an FDA 510(k) premarket notification submitted by Lifeline Instruments, Inc. for the device "DONORMATIC (BLOOD COLLECTION DEVICE)". The FDA issued a decision of Substantially Equivalent on December 6, 1976. The device falls under product code KSQ (Device, Blood Mixing And Blood Weighing), a Class I device regulated under 21 CFR 864.9195. Lifeline Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 1976
- Date Received
- September 30, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Blood Mixing And Blood Weighing
- Device Class
- Class I
- Regulation Number
- 864.9195
- Review Panel
- HE
- Submission Type