PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
FDA 510(k) clearance K072599 · decided 2007-12-20
Clearance details
- K-number
- K072599
- Device name
- PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
- Applicant
- Diadexus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-14
- Decision date
- 2007-12-20
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- NOE
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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