The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer Hemoglobin Reagent Strips.
| Device ID | K822044 |
| 510k Number | K822044 |
| Device Name: | SERALYZER HEMOGLOBIN REAGENT STRIPS |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-12 |
| Decision Date | 1982-07-30 |