510(k) K843794
- Device
- LATEX-R RICKETTSII
- Applicant
- HEALTH RESEARCH, INC.
- 510(k) number
- K843794
- Product code
- GPP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-04
- Date received
- 1984-09-27
- Regulation
- 866.3500
- Classification name
- Antiserum, Rocky Mountain Spotted Fever
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROGER S ROSENTHAL
- Address
- 1315 Empire State Plz. Mayor Erastus Corning 2 Tower Albany NY US 12237 12237
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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