The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Iron Test #'s 42376/93,42324/r1a,42324/r1b,42324/r.
| Device ID | K930166 |
| 510k Number | K930166 |
| Device Name: | IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-13 |
| Decision Date | 1993-04-21 |