510(k) K855233
- Device
- DIAGNOSTIC REAGENT SET-RPLA
- Applicant
- OXOID U.S.A., INC.
- 510(k) number
- K855233
- Product code
- GTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-04
- Date received
- 1985-12-31
- 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
- RUTH KEMP
- Address
- 9017 Red Branch Rd. Columbia MD US 21045 21045
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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