510(k) K972975
- Device
- LIGHT DIAGNOSTICS RABIES DFA REAGENT
- Applicant
- LIGHT DIAGNOSTICS
- 510(k) number
- K972975
- Product code
- GOI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-12-22
- Date received
- 1997-08-11
- Regulation
- 866.3460
- Classification name
- Antiserum, Fluorescent, Rabies Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CINDY D PENNY
- Address
- 28835 Single Oak Dr. Temecula CA US 92590 92590
FDA Registration Numbers#
- 1643621
Source Documents#
Other 510(k) Records For Product Code GOI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K820499 | FITC ANTI-RABIES MONOCLONAL GLOBULIN | Centocor, Inc. | 1982-04-16 |
Legacy Summary#
summary
FDA Review#
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