Arbovirus Igg Ifa Test
FDA 510(k) K913617 · Hillcrest Biologicals
510(k) numberK913617
Submission
- Device name
- Arbovirus Igg Ifa Test
- Applicant
- Hillcrest Biologicals
Cypress, CA, US - Received
- August 13, 1991
- Decision date
- December 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GQC – Antisera, Cf, Equine Encephalitis Virus, Eee, Wee
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3240
- Specialty
- Microbiology
Other 510(k)s with product code GQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K913618 | Arbovirus Igm Ifa TestGQC · Traditional | Hillcrest Biologicals | 12/03/1992SE |
More from Hillcrest Biologicals
| 510(k) | Device | Decision |
|---|---|---|
| K913618 | Arbovirus Igm 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 |
| K875170 | Ebna AntibodyLLM · Traditional | 05/23/1988SE |
Questions and answers
When was Arbovirus Igg Ifa Test cleared by the FDA?
Arbovirus Igg Ifa Test (K913617) received a 510(k) decision of Substantially Equivalent on December 3, 1992, 478 days after the submission was received.
What is the product code of K913617?
The FDA product code is GQC – Antisera, Cf, Equine Encephalitis Virus, Eee, Wee, a Class I (low risk) device regulated under 21 CFR 866.3240.