510(k) K831655
- Device
- SPECTRUM-10
- Applicant
- AUSTIN BIOLOGICAL LABORATORIES
- 510(k) number
- K831655
- Product code
- JSZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-17
- Date received
- 1983-05-23
- Regulation
- 866.2660
- Classification name
- Kit, Identification, Pseudomonas
- 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
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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