510(k) K812181
- Device
- STAPHYLOCOCCAL PROTEIN A INSOLUBLE
- Applicant
- OXOID U.S.A., INC.
- 510(k) number
- K812181
- Product code
- LHJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-08-25
- Date received
- 1981-08-03
- Regulation
- 866.3700
- Classification name
- Staphylococcus Aureus Protein A Insoluble
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8023060
- 3035708936
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LHJ #
Legacy Summary#
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FDA Review#
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