Echo Type 4 CF Antigen
FDA 510(k) K844695 · Hillcrest Biologicals
510(k) numberK844695
Submission
- Device name
- Echo Type 4 CF Antigen
- Applicant
- Hillcrest Biologicals
Long Beach, CA, US - Received
- December 3, 1984
- Decision date
- March 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNL – Antigens, Cf (Including Cf Control), Echovirus 1-34
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3205
- Specialty
- Microbiology
Other 510(k)s with product code GNL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K844967 | Echo Type 9 CF AntigenGNL · Traditional | Hillcrest Biologicals | 03/05/1985SE |
More from Hillcrest Biologicals
| 510(k) | Device | Decision |
|---|---|---|
| K913618 | Arbovirus Igm Ifa TestGQC · Traditional | 12/03/1992SE |
| K913617 | Arbovirus Igg Ifa TestGQC · Traditional | 12/03/1992SE |
| K922374 | Q Fever Igm Ifa TestGPJ · Traditional | 10/21/1992SE |
| K913906 | Q Fever Igg Ifa TestGPJ · Traditional | 10/21/1992SE |
| K900206 | Lyme Disease Igm ElisaLSR · Traditional | 06/28/1991SE |
| K896594 | Ebv Vca Antibody (Igm)LJN · Traditional | 01/16/1990SE |
| K884829 | Ebv Early Antigen (R+D)JRY · Traditional | 04/12/1989SE |
| K883767 | Lyme Disease Ifa (Igm)LSR · Traditional | 03/15/1989SE |
| K884591 | Ebv-Vca Antibody (Igg)GNP · Traditional | 01/24/1989SE |
| K883487 | Lyme Disease Ifa (Igg)LSR · Traditional | 12/13/1988SE |
Questions and answers
When was Echo Type 4 CF Antigen cleared by the FDA?
Echo Type 4 CF Antigen (K844695) received a 510(k) decision of Substantially Equivalent on March 5, 1985, 92 days after the submission was received.
What is the product code of K844695?
The FDA product code is GNL – Antigens, Cf (Including Cf Control), Echovirus 1-34, a Class I (low risk) device regulated under 21 CFR 866.3205.