The following data is part of a premarket notification filed by Meretek Diagnostics, Inc. with the FDA for Meretek Breath Test For H.pylori Collection Kit.
| Device ID | K952220 |
| 510k Number | K952220 |
| Device Name: | MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT |
| Classification | Helicobacter Pylori |
| Applicant | MERETEK DIAGNOSTICS, INC. 1709 DRYDEN RD. SUITE 1513 Houston, TX 77030 |
| Contact | Claudia T Hitchcock |
| Correspondent | Claudia T Hitchcock MERETEK DIAGNOSTICS, INC. 1709 DRYDEN RD. SUITE 1513 Houston, TX 77030 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-11 |
| Decision Date | 1996-09-17 |