510(k) K860557
- Device
- LATEX R. TYPHI
- Applicant
- HEALTH RESEARCH, INC.
- 510(k) number
- K860557
- Product code
- GPM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-21
- Date received
- 1986-02-14
- Regulation
- 866.3500
- Classification name
- Antiserum, Murine Typhus Fever
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL G BARTH
- 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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