The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Easy-test Hemoglobin (hgb) Item #16685.
| Device ID | K872653 |
| 510k Number | K872653 |
| Device Name: | EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 |
| Classification | Whole Blood Hemoglobin Determination |
| 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 | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-07 |
| Decision Date | 1987-07-23 |