510(k) K820499
- Device
- FITC ANTI-RABIES MONOCLONAL GLOBULIN
- Applicant
- CENTOCOR, INC.
- 510(k) number
- K820499
- Product code
- GOI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-04-16
- Date received
- 1982-02-23
- Regulation
- 866.3460
- Classification name
- Antiserum, Fluorescent, Rabies Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1643621
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GOI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972975 | LIGHT DIAGNOSTICS RABIES DFA REAGENT | Light Diagnostics | 1998-12-22 |
Legacy Summary#
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FDA Review#
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