510(k) K885310
K885310 is an FDA 510(k) premarket notification submitted by Whittaker Bioproducts, Inc. for the device "MURINE MONOCLONAL ANTI-ADENOVIRUS IGG". The FDA issued a decision of Substantially Equivalent on February 16, 1989. The device falls under product code GNY (Antisera, Fluorescent, Adenovirus 1-33), a Class I device regulated under 21 CFR 866.3020. Whittaker Bioproducts, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1989
- Date Received
- December 29, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, Adenovirus 1-33
- Device Class
- Class I
- Regulation Number
- 866.3020
- Review Panel
- MI
- Submission Type