510(k) K791341
K791341 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "HUMAN ALPHA, ACID GLYCOPROTEIN". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code DEX (Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5420. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1979
- Date Received
- July 16, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5420
- Review Panel
- IM
- Submission Type