QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
FDA 510(k) clearance K991062 · decided 1999-09-21
Clearance details
- K-number
- K991062
- Device name
- QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
- Applicant
- Immunetics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-31
- Decision date
- 1999-09-21
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- LSR
- Device class
- 2
- Regulation number
- 866.3830
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cambridge,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.