The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Hemohlobin A2 Control-lyophilized.
| Device ID | K801410 |
| 510k Number | K801410 |
| Device Name: | HEMOHLOBIN A2 CONTROL-LYOPHILIZED |
| Classification | Hemoglobin A2 Quantitation |
| Applicant | ISOLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPD |
| CFR Regulation Number | 864.7400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-16 |
| Decision Date | 1980-07-21 |