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 |