LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
FDA 510(k) clearance K081527 · decided 2009-04-01
Clearance details
- K-number
- K081527
- Device name
- LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
- Applicant
- Millipore Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-06-02
- Decision date
- 2009-04-01
- Days to decision
- 303 days
- Clearance type
- Traditional
- Product code
- GQL
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.