The following data is part of a premarket notification filed by Auspharm Intl. Ltd. with the FDA for Clotest, Campylobacter Pylori Urease Enzyme Test.
| Device ID | K882199 |
| 510k Number | K882199 |
| Device Name: | CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST |
| Classification | Helicobacter Pylori |
| Applicant | AUSPHARM INTL. LTD. 979 JULIUS COURT North Merrick, NY 11566 |
| Contact | Fred Landsman |
| Correspondent | Fred Landsman AUSPHARM INTL. LTD. 979 JULIUS COURT North Merrick, NY 11566 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-25 |
| Decision Date | 1988-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00350770927459 | K882199 | 000 |
| 00350770926636 | K882199 | 000 |