510(k) K840589
K840589 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "TRI-TUBE RIA". The FDA issued a decision of Substantially Equivalent on Mar 9, 1984. The device falls under product code KHQ (Radioassay, Triiodothyronine Uptake), a Class II device regulated under 21 CFR 862.1715. Nuclear Medical Laboratories, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 9, 1984
- Date Received
- Feb 9, 1984
- 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
- 510(k) Exempt