510(k) K983774
K983774 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "UALB". The FDA issued a decision of Substantially Equivalent on January 28, 1999. The device falls under product code JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1999
- Date Received
- October 26, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device Class
- Class I
- Regulation Number
- 862.1645
- Review Panel
- CH
- Submission Type