Enterovirus Blend Monoclonal Antibodies
FDA 510(k) K940027 · Chemicon Intl., Inc.
510(k) numberK940027
Submission
- Device name
- Enterovirus Blend Monoclonal Antibodies
- Applicant
- Chemicon Intl., Inc.
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 |
| K940026 | Poliovirus Blend Monoclonal AntibodiesGOE · Traditional | Light Diagnostics | 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 |
More from Light Diagnostics
| 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 |
| K940472 | Coxsackievirus B5 Monoclonal AntibodyGNM · Traditional | 09/08/1995SE |
| K940471 | Coxsackievirus B Blend Monoclonal AntibodiesGNM · Traditional | 09/08/1995SE |
| K936145 | Coxsackievirus B1 Monoclonal AntibodyGNM · 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 Enterovirus Blend Monoclonal Antibodies cleared by the FDA?
Enterovirus Blend Monoclonal Antibodies (K940027) 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 K940027?
The FDA product code is GOE – Antisera, Fluorescent, Poliovirus 1-3, a Class I (low risk) device regulated under 21 CFR 866.3405.