AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI
FDA 510(k) clearance K992124 · decided 1999-09-20
Clearance details
- K-number
- K992124
- Device name
- AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI POLAR LIPIDS BULK BDRL ANTIGEN, AVANTI
- Applicant
- Avanti Polar Lipids, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-23
- Decision date
- 1999-09-20
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- GMQ
- Device class
- 2
- Regulation number
- 866.3820
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Alabaster, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.