510(k) K813191
- Device
- SHIGELLA SERA-CHEK
- Applicant
- LAB ABILITY, INC.
- 510(k) number
- K813191
- Product code
- LIA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-12-03
- Date received
- 1981-11-17
- Regulation
- 866.3660
- Classification name
- Antigens, All Groups, Shigella Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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