The following data is part of a premarket notification filed by Flexsite Diagnostics, Inc. with the FDA for Ezchek/hba Blood Collection Kit.
| Device ID | K971919 |
| 510k Number | K971919 |
| Device Name: | EZCHEK/HBA BLOOD COLLECTION KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | FLEXSITE DIAGNOSTICS, INC. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone FLEXSITE DIAGNOSTICS, INC. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-23 |
| Decision Date | 1997-09-05 |
| Summary: | summary |