510(k) K992993
- Device
- ETEST FOR QUINUPRISTIN/DALFOPRISTIN
- Applicant
- AB BIODISK
- 510(k) number
- K992993
- Product code
- LTX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-11-16
- Date received
- 1999-09-07
- Regulation
- 866.1620
- Classification name
- Discs, Elution
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNE BOLMSTROM
- Address
- Dalvagen 10 Solna SE 16956 16956
FDA Registration Numbers#
- 9615754
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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