The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Flexsure Hp.
| Device ID | K934863 |
| 510k Number | K934863 |
| Device Name: | FLEXSURE HP |
| Classification | Helicobacter Pylori |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 225 BAYPOINTE PKWY. San Jose, CA 95134 -1622 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel SMITH KLINE DIAGNOSTICS, INC. 225 BAYPOINTE PKWY. San Jose, CA 95134 -1622 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1994-05-18 |