The following data is part of a premarket notification filed by Chemtrak, Inc. with the FDA for Accumeter H. Pylori Test.
| Device ID | K965099 |
| 510k Number | K965099 |
| Device Name: | ACCUMETER H. PYLORI TEST |
| Classification | Helicobacter Pylori |
| Applicant | CHEMTRAK, INC. 929 EAST ARQUES AVE. Sunnyvale, CA 94086 -4520 |
| Contact | Rodger J Richeal |
| Correspondent | Rodger J Richeal CHEMTRAK, INC. 929 EAST ARQUES AVE. Sunnyvale, CA 94086 -4520 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-20 |
| Decision Date | 1997-02-20 |