510(k) K833738
- Device
- LEAP STREP TEST KIT
- Applicant
- COOPER BIOMEDICAL, INC.
- 510(k) number
- K833738
- Product code
- GTP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-12-27
- Date received
- 1983-10-25
- Regulation
- 866.3720
- Classification name
- Exoenzymes, Multiple, Streptococcal
- Medical specialty
- Microbiology
- Review panel
- Immunology
- 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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