510(k) K781296
K781296 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "THYRO-SHURE". The FDA issued a decision of Substantially Equivalent on Aug 31, 1978. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Nuclear Medical Laboratories, Inc. has 23 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 31, 1978
- Date Received
- Jul 27, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Radioimmunoassay, Thyroid-Stimulating Hormone
- Device Class
- Class II
- Regulation Number
- 862.1690
- Review Panel
- CH
- Submission Type
- 510(k)