EZ-HBT HELICOBACTER BLOOD TEST
FDA 510(k) clearance K990931 · decided 1999-09-24
Clearance details
- K-number
- K990931
- Device name
- EZ-HBT HELICOBACTER BLOOD TEST
- Applicant
- Metabolic Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-19
- Decision date
- 1999-09-24
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- MSQ
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Nashua, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.