510(k) K772177
K772177 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "TRI-TAB-RIA". The FDA issued a decision of Substantially Equivalent on Dec 22, 1977. The device falls under product code CDP (Radioimmunoassay, Total Triiodothyronine), a Class II device regulated under 21 CFR 862.1710. Nuclear Medical Laboratories, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 1977
- Date Received
- Nov 21, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Total Triiodothyronine
- Device Class
- Class II
- Regulation Number
- 862.1710
- Review Panel
- CH
- Submission Type
- 510(k) Exempt