The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Abbott Quickstart Albumin Bcp (albp)#5a16.
| Device ID | K913025 |
| 510k Number | K913025 |
| Device Name: | ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-09 |
| Decision Date | 1991-10-09 |