510(k) K894624
K894624 is an FDA 510(k) premarket notification submitted by Bion Ent., Ltd. for the device "MUMPS VIRUS". The FDA issued a decision of Substantially Equivalent on October 16, 1989. The device falls under product code GRA (Antiserum, Fluorescent, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Bion Ent., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 1989
- Date Received
- July 20, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Fluorescent, Mumps Virus
- Device Class
- Class I
- Regulation Number
- 866.3380
- Review Panel
- MI
- Submission Type