Poliovirus Blend Monoclonal Antibodies
FDA 510(k) K940026 · Light Diagnostics
510(k) numberK940026
Submission
- Device name
- Poliovirus Blend Monoclonal Antibodies
- Applicant
- Light Diagnostics
Temecula, CA, US - Received
- January 3, 1994
- Decision date
- September 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GOE – Antisera, Fluorescent, Poliovirus 1-3
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3405
- Specialty
- Microbiology
Other 510(k)s with product code GOE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940473 | Enterovirus 71 Monoclonal AntibodyGOE · Traditional | Chemicon Intl., Inc. | 09/12/1995SE |
| K940034 | Poliovirus 2 Monoclonal AntibodyGOE · Traditional | Light Diagnostics | 09/12/1995SE |
| K940027 | Enterovirus Blend Monoclonal AntibodiesGOE · Traditional | Chemicon Intl., Inc. | 09/12/1995SE |
| K940017 | Poliovirus 3 Monoclonal AntibodyGOE · Traditional | Light Diagnostics | 09/12/1995SE |
| K940363 | Enterovirus 70 Monclonal AntibodyGOE · Traditional | Light Diagnostics | 09/08/1995SE |
| K940018 | Poliovirus 1 Monoclonal AntibodyGOE · Traditional | Light Diagnostics | 09/08/1995SE |
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| K990141 | Light Diagnostics Simulfluor Hsv/Vzv Immunoflourescence Assay, Model 3295GQW · Traditional | 10/19/1999SE |
| K972975 | Light Diagnostics Rabies Dfa ReagentGOI · Traditional | 12/22/1998SE |
| 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 |
| 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 Poliovirus Blend Monoclonal Antibodies cleared by the FDA?
Poliovirus Blend Monoclonal Antibodies (K940026) received a 510(k) decision of Substantially Equivalent on September 12, 1995, 617 days after the submission was received.
What is the product code of K940026?
The FDA product code is GOE – Antisera, Fluorescent, Poliovirus 1-3, a Class I (low risk) device regulated under 21 CFR 866.3405.