The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Surecell(tm) Hcg Urine Test Kit/modification.
| Device ID | K915701 |
| 510k Number | K915701 |
| Device Name: | KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Norman H Geil |
| Correspondent | Norman H Geil EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-01-27 |