Coxsackievirus B4 Monoclonal Antibody
FDA 510(k) K936253 · Light Diagnostics
510(k) numberK936253
Submission
- Device name
- Coxsackievirus B4 Monoclonal Antibody
- Applicant
- Light Diagnostics
Temecula, CA, US - Received
- December 30, 1993
- Decision date
- September 8, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GNM – Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3145
- Specialty
- Microbiology
Other 510(k)s with product code GNM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940472 | Coxsackievirus B5 Monoclonal AntibodyGNM · Traditional | Chemicon Intl., Inc. | 09/08/1995SE |
| K940471 | Coxsackievirus B Blend Monoclonal AntibodiesGNM · Traditional | Chemicon Intl., Inc. | 09/08/1995SE |
| K936254 | Cocksackievirus B6 Monoclonal AntibodyGNM · Traditional | Light Diagnostics | 09/08/1995SE |
| K936252 | Coxsackievirus B@ Monoclonal AntibodyGNM · Traditional | Light Diagnostics | 09/08/1995SE |
| K936251 | Coxsackievirus B3 Monoclonal AntibodyGNM · Traditional | Light Diagnostics | 09/08/1995SE |
| K936145 | Coxsackievirus B1 Monoclonal AntibodyGNM · Traditional | Chemicon Intl., Inc. | 09/08/1995SE |
| K936089 | Coxsackie A24 Virus Monoclonal AntibodyGNM · Traditional | Chemicon Intl., Inc. | 09/08/1995SE |
| K936073 | Enterovirus Monocl Antibody Det of Coxsackie A9 VirusGNM · Traditional | Chemicon Intl., Inc. | 09/08/1995SE |
More from Chemicon Intl., 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 |
| 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 |
| 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 |
Questions and answers
When was Coxsackievirus B4 Monoclonal Antibody cleared by the FDA?
Coxsackievirus B4 Monoclonal Antibody (K936253) received a 510(k) decision of Substantially Equivalent on September 8, 1995, 617 days after the submission was received.
What is the product code of K936253?
The FDA product code is GNM – Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6, a Class I (low risk) device regulated under 21 CFR 866.3145.