510(k) K760086
K760086 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "TRAY, BLOOD SAMPLING (PULSATOR II)". The FDA issued a decision of Substantially Equivalent on July 16, 1976. The device falls under product code GJE (Tray, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1976
- Date Received
- June 21, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type