Coxsackievirus B1 Monoclonal Antibody
FDA 510(k) K936145 · Chemicon Intl., Inc.
510(k) numberK936145
Submission
- Device name
- Coxsackievirus B1 Monoclonal Antibody
- Applicant
- Chemicon Intl., Inc.
Temecula, CA, US - Received
- December 27, 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 |
| K936253 | Coxsackievirus B4 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 |
| 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 |
|---|---|---|
| K992252 | Light Diagnostics Pneumocystis Carinii Dfa, Model 31965LYF · Special | 08/10/1999SE |
| K940473 | Enterovirus 71 Monoclonal AntibodyGOE · Traditional | 09/12/1995SE |
| K940027 | Enterovirus Blend Monoclonal AntibodiesGOE · Traditional | 09/12/1995SE |
| K940472 | Coxsackievirus B5 Monoclonal AntibodyGNM · Traditional | 09/08/1995SE |
| K940471 | Coxsackievirus B Blend Monoclonal AntibodiesGNM · Traditional | 09/08/1995SE |
| K936089 | Coxsackie A24 Virus Monoclonal AntibodyGNM · Traditional | 09/08/1995SE |
| K936073 | Enterovirus Monocl Antibody Det of Coxsackie A9 VirusGNM · Traditional | 09/08/1995SE |
Questions and answers
When was Coxsackievirus B1 Monoclonal Antibody cleared by the FDA?
Coxsackievirus B1 Monoclonal Antibody (K936145) received a 510(k) decision of Substantially Equivalent on September 8, 1995, 620 days after the submission was received.
What is the product code of K936145?
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.