Q Fever Igm Ifa Test
FDA 510(k) K922374 · Hillcrest Biologicals
510(k) numberK922374
Submission
- Device name
- Q Fever Igm Ifa Test
- Applicant
- Hillcrest Biologicals
Cypress, CA, US - Received
- May 20, 1992
- Decision date
- October 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GPJ – Antiserum, Fluorescent, Q Fever
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3500
- Specialty
- Microbiology
Other 510(k)s with product code GPJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K913906 | Q Fever Igg Ifa TestGPJ · Traditional | Hillcrest Biologicals | 10/21/1992SE |
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 |
| 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 Q Fever Igm Ifa Test cleared by the FDA?
Q Fever Igm Ifa Test (K922374) received a 510(k) decision of Substantially Equivalent on October 21, 1992, 154 days after the submission was received.
What is the product code of K922374?
The FDA product code is GPJ – Antiserum, Fluorescent, Q Fever, a Class I (low risk) device regulated under 21 CFR 866.3500.