Herpes-Iha Kit
FDA 510(k) K822095 · Hillcrest Biologicals
510(k) numberK822095
Submission
- Device name
- Herpes-Iha Kit
- Applicant
- Hillcrest Biologicals
Mchenry, IL, US - Received
- July 16, 1982
- Decision date
- April 5, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Planmeca USA, Inc.
| 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 Herpes-Iha Kit cleared by the FDA?
Herpes-Iha Kit (K822095) received a 510(k) decision of Substantially Equivalent on April 5, 1983, 263 days after the submission was received.
What is the product code of K822095?
The FDA product code is KLC – Chair, Dental, With Operative Unit, a Class I (low risk) device regulated under 21 CFR 872.6250.