The following data is part of a premarket notification filed by Smithkline Diagnostics, Inc. with the FDA for Flexsure Obt.
| Device ID | K961062 |
| 510k Number | K961062 |
| Device Name: | FLEXSURE OBT |
| Classification | Reagent, Occult Blood |
| Applicant | SMITHKLINE DIAGNOSTICS, INC. 606 ELMWOOD AVE. COURT III Sharon Hill, PA 19079 -1031 |
| Contact | Marshall C Mccarty |
| Correspondent | Marshall C Mccarty SMITHKLINE DIAGNOSTICS, INC. 606 ELMWOOD AVE. COURT III Sharon Hill, PA 19079 -1031 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-18 |
| Decision Date | 1996-11-06 |
| Summary: | summary |