The following data is part of a premarket notification filed by Hana Biologics, Inc. with the FDA for Amnistat-flm.
Device ID | K822150 |
510k Number | K822150 |
Device Name: | AMNISTAT-FLM |
Classification | Chromatographic Separation, Lecithin/sphingomyelin Ratio |
Applicant | HANA BIOLOGICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JHG |
CFR Regulation Number | 862.1455 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-22 |
Decision Date | 1982-10-21 |