The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Surecell Hcg-serum/urine Test Kit, Modification.
| Device ID | K936138 |
| 510k Number | K936138 |
| Device Name: | KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Contact | Yvonne E Middlefell |
| Correspondent | Yvonne E Middlefell EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 -1131 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-23 |
| Decision Date | 1994-04-08 |