ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
FDA 510(k) clearance K974810 · decided 1998-02-05
Clearance details
- K-number
- K974810
- Device name
- ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
- Applicant
- Boston Biomedica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-23
- Decision date
- 1998-02-05
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- LSR
- Device class
- 2
- Regulation number
- 866.3830
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- West Bridgewater, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.