510(k) K972697
K972697 is an FDA 510(k) premarket notification submitted by Tosoh Medics, Inc. for the device "AIA-PACK IGE II ASSAY". The FDA issued a decision of Substantially Equivalent on October 3, 1997. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Tosoh Medics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 1997
- Date Received
- July 18, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ige, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type