The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Flexsure Hp,controls For Flexsurehp,flexpack Hp(abbott Diagnostics)andcontrols For Flexpack Hp (abbott Diagnostics).
| Device ID | K960183 |
| 510k Number | K960183 |
| Device Name: | FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) |
| Classification | Helicobacter Pylori |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 225 BAYPOINTE PKWY. San Jose, CA 95134 -1622 |
| Contact | Marshall C Mccarty |
| Correspondent | Marshall C Mccarty 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 | 1996-01-16 |
| Decision Date | 1996-06-07 |
| Summary: | summary |