ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
FDA 510(k) clearance K973000 · decided 1998-02-26
Clearance details
- K-number
- K973000
- Device name
- ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
- Applicant
- Alimenterics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-12
- Decision date
- 1998-02-26
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- MSQ
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Morris Plains, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.