510(k) K912937
K912937 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "SR1 FREE T4 ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on Nov 19, 1991. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 19, 1991
- Date Received
- Jul 5, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Free Thyroxine
- Device Class
- Class II
- Regulation Number
- 862.1695
- Review Panel
- CH
- Submission Type