The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Standard Human Plasma.
Device ID | K924393 |
510k Number | K924393 |
Device Name: | STANDARD HUMAN PLASMA |
Classification | System, Multipurpose For In Vitro Coagulation Studies |
Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
Contact | Joseph Kiceina |
Correspondent | Joseph Kiceina BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
Product Code | JPA |
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 | 1992-11-16 |