510(k) K013420
K013420 is an FDA 510(k) premarket notification submitted by Awareness Technology, Inc. for the device "CHEMWELL, ALSO KNOWN AS PROJECT 2900". The FDA issued a decision of Substantially Equivalent on July 19, 2002. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Awareness Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2002
- Date Received
- October 15, 2001
- Clearance Type
- Abbreviated
- 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