The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Antiserum To Human Albumin.
Device ID | K972929 |
510k Number | K972929 |
Device Name: | N ANTISERUM TO HUMAN ALBUMIN |
Classification | Albumin, Antigen, Antiserum, Control |
Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Contact | Ruth Forstadt |
Correspondent | Ruth Forstadt BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Product Code | DCF |
CFR Regulation Number | 866.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-08 |
Decision Date | 1997-10-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768038020 | K972929 | 000 |
00842768038013 | K972929 | 000 |