The following data is part of a premarket notification filed by Metabolic Solutions, Inc. with the FDA for Ez-hbt Helicobacter Blood Test.
| Device ID | K990931 |
| 510k Number | K990931 |
| Device Name: | EZ-HBT HELICOBACTER BLOOD TEST |
| Classification | Test, Urea (breath Or Blood) |
| Applicant | METABOLIC SOLUTIONS, INC. 460 AMHERST ST. Nashua, NH 03063 -1220 |
| Contact | David A Wagner |
| Correspondent | David A Wagner METABOLIC SOLUTIONS, INC. 460 AMHERST ST. Nashua, NH 03063 -1220 |
| Product Code | MSQ |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-19 |
| Decision Date | 1999-09-24 |
| Summary: | summary |