510(k) K981295
K981295 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "UPRO". The FDA issued a decision of Substantially Equivalent on October 1, 1998. The device falls under product code JGQ (Turbidimetric, Total Protein), a Class II device regulated under 21 CFR 862.1635. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 1998
- Date Received
- April 9, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Turbidimetric, Total Protein
- Device Class
- Class II
- Regulation Number
- 862.1635
- Review Panel
- CH
- Submission Type