510(k) K961312
K961312 is an FDA 510(k) premarket notification submitted by Hemocue, Inc. for the device "HEMOCUE B-HEMOGLOBIN SYSTEM". The FDA issued a decision of Substantially Equivalent on September 24, 1996. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Hemocue, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1996
- Date Received
- April 4, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Hemoglobin, Automated
- Device Class
- Class II
- Regulation Number
- 864.5620
- Review Panel
- HE
- Submission Type