510(k) K960195
K960195 is an FDA 510(k) premarket notification submitted by Franklin Diagnostics, Inc. for the device "THYROCHEK ONE-STEP RAPID TSH ASSAY". The FDA issued a decision of Substantially Equivalent on Apr 15, 1996. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Franklin Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 15, 1996
- Date Received
- Jan 16, 1996
- 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