510(k) K943557
K943557 is an FDA 510(k) premarket notification submitted by Dako Diagnostics , Ltd. for the device "IMAGEN". The FDA issued a decision of Substantially Equivalent on January 9, 1995. The device falls under product code GQS (Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4), a Class I device regulated under 21 CFR 866.3400. Dako Diagnostics , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1995
- Date Received
- July 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
- Device Class
- Class I
- Regulation Number
- 866.3400
- Review Panel
- MI
- Submission Type