The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Pathoplasma(r) I & Ii (path Citrated Human Plasma).
| Device ID | K924401 |
| 510k Number | K924401 |
| Device Name: | PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) |
| Classification | Control, Plasma, Abnormal |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Lori Baranauskas |
| Correspondent | Lori Baranauskas BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-31 |
| Decision Date | 1994-02-22 |