510(k) K812329
K812329 is an FDA 510(k) premarket notification submitted by Amf Biological And Diagnostics Co. for the device "ZETA-SERA D". The FDA issued a decision of Substantially Equivalent on Sep 1, 1981. The device falls under product code KIS (Sera, Animal And Human), a Class I device regulated under 21 CFR 864.2800. Amf Biological And Diagnostics Co. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 1, 1981
- Date Received
- Aug 18, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Sera, Animal And Human
- Device Class
- Class I
- Regulation Number
- 864.2800
- Review Panel
- PA
- Submission Type
- 510(k) Exempt