Light Diagnostics Rabies Dfa Reagent
FDA 510(k) K972975 · Light Diagnostics
510(k) numberK972975
Submission
- Device name
- Light Diagnostics Rabies Dfa Reagent
- Applicant
- Light Diagnostics
Temecula, CA, US - Received
- August 11, 1997
- Decision date
- December 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GOI – Antiserum, Fluorescent, Rabies Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3460
- Specialty
- Microbiology
Other 510(k)s with product code GOI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K820499 | Fitc Anti-Rabies Monoclonal GlobulinGOI · Traditional | Centocor, Inc. | 04/16/1982SE |
More from Centocor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991880 | Light Diagnostics Simulfluor HSV 1/2 Immunofluorecence AssayGQN · Traditional | 11/09/1999SE |
| K990141 | Light Diagnostics Simulfluor Hsv/Vzv Immunoflourescence Assay, Model 3295GQW · Traditional | 10/19/1999SE |
| K974302 | Light Diagnostics Simulfluor Flu A/Flu BGNW · Traditional | 04/08/1998SE |
| K951821 | Cytomegalovirus Direct Immunofluorescence AssayLIN · Traditional | 06/07/1996SE |
| K951799 | Varicella-Zoster Virus Direct Immunofluorescence AssayGQX · Traditional | 03/20/1996SE |
| K940034 | Poliovirus 2 Monoclonal AntibodyGOE · Traditional | 09/12/1995SE |
| K940026 | Poliovirus Blend Monoclonal AntibodiesGOE · Traditional | 09/12/1995SE |
| K940017 | Poliovirus 3 Monoclonal AntibodyGOE · Traditional | 09/12/1995SE |
| K940363 | Enterovirus 70 Monclonal AntibodyGOE · Traditional | 09/08/1995SE |
| K940018 | Poliovirus 1 Monoclonal AntibodyGOE · Traditional | 09/08/1995SE |
Questions and answers
When was Light Diagnostics Rabies Dfa Reagent cleared by the FDA?
Light Diagnostics Rabies Dfa Reagent (K972975) received a 510(k) decision of Substantially Equivalent on December 22, 1998, 498 days after the submission was received.
What is the product code of K972975?
The FDA product code is GOI – Antiserum, Fluorescent, Rabies Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3460.