The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Hemoglobin Reagent Set.
| Device ID | K860475 |
| 510k Number | K860475 |
| Device Name: | HEMOGLOBIN REAGENT SET |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Contact | David Callender |
| Correspondent | David Callender STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-07 |
| Decision Date | 1986-03-03 |