The following data is part of a premarket notification filed by Hana Biologics, Inc. with the FDA for Amnio Stat-flm Agglutination Test.
| Device ID | K834616 |
| 510k Number | K834616 |
| Device Name: | AMNIO STAT-FLM AGGLUTINATION TEST |
| 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 | 1983-12-14 |
| Decision Date | 1984-05-25 |