510(k) K854946
K854946 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDXR 5-HIAA (URINE)". The FDA issued a decision of Substantially Equivalent on January 17, 1986. The device falls under product code CDA (Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin), a Class I device regulated under 21 CFR 862.1390. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1986
- Date Received
- December 10, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
- Device Class
- Class I
- Regulation Number
- 862.1390
- Review Panel
- CH
- Submission Type