The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Unistep Capillary Blood Collection System.
| Device ID | K875354 |
| 510k Number | K875354 |
| Device Name: | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
| Contact | Robert Mcewen |
| Correspondent | Robert Mcewen ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-31 |
| Decision Date | 1988-02-17 |