510(k) K851949
- Device
- STAPHAUREX ZL30
- Applicant
- WELLCOME DIAGNOSTICS
- 510(k) number
- K851949
- Product code
- GTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-22
- Date received
- 1985-05-03
- Regulation
- 866.3700
- Classification name
- Antisera, Fluorescent, All Types, Staphylococcus Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MAX D MOODY
- Address
- 3030 Cornwallis Rd. Research Triangle Pk NC US 27709 27709
FDA Registration Numbers#
- 3003750284
- 1119779
- 8010096
- 8010383
- 2246703
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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