510(k) K934312
K934312 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM(TM) T-UPTAKE". The FDA issued a decision of Substantially Equivalent on June 21, 1994. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1994
- Date Received
- September 1, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioassay, Triiodothyronine Uptake
- Device Class
- Class II
- Regulation Number
- 862.1715
- Review Panel
- CH
- Submission Type