The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Emds(tm) Albumin Testpacks, #67652/95.
| Device ID | K863004 |
| 510k Number | K863004 |
| Device Name: | EMDS(TM) ALBUMIN TESTPACKS, #67652/95 |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Raymond L Miller |
| Correspondent | Raymond L Miller 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 | 1986-08-08 |
| Decision Date | 1986-09-16 |