The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Alpha-1-antitrypsin (aat).
Device ID | K964766 |
510k Number | K964766 |
Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) |
Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
Contact | Annette Hellie |
Correspondent | Annette Hellie BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
Product Code | DEM |
CFR Regulation Number | 866.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-27 |
Decision Date | 1997-04-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15099590224042 | K964766 | 000 |