IRON TEST
Photometric Method, Iron (non-heme)
EM DIAGNOSTIC SYSTEMS, INC.
The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Iron Test.
Pre-market Notification Details
| Device ID | K935176 |
| 510k Number | K935176 |
| Device Name: | IRON TEST |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. DIV. OF EM INDUSTRIES INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Carol Faulkner |
| Correspondent | Carol Faulkner EM DIAGNOSTIC SYSTEMS, INC. DIV. OF EM INDUSTRIES 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 | 1993-10-27 |
| Decision Date | 1993-12-16 |
Trademark Results [IRON TEST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IRON TEST 86150259 4717590 Live/Registered |
Fitness Publications, Inc. 2013-12-20 |
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