510(k) K911634
K911634 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST". The FDA issued a decision of Substantially Equivalent on Jun 24, 1991. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Immunotech Corp. has 40 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 24, 1991
- Date Received
- Apr 11, 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
- 510(k)