510(k) K851234
K851234 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "A-JUST TURBIDITY METER". The FDA issued a decision of Substantially Equivalent on April 29, 1985. The device falls under product code JQX (Nephelometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2700. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1985
- Date Received
- March 26, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nephelometer, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2700
- Review Panel
- CH
- Submission Type