Histoset Immunoperofidase Tissue
FDA 510(k) K821411 · Immulok, Inc.
510(k) numberK821411
Submission
- Device name
- Histoset Immunoperofidase Tissue
- Applicant
- Immulok, Inc.
Mchenry, IL, US - Received
- May 12, 1982
- Decision date
- June 25, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQL – Antisera, Fluorescent, Herpesvirus Hominis 1,2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
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|---|---|---|---|
| K091753 | Elvis HSV Id and D3 Typing Test SystemGQL · Traditional | Diagnostic Hybrids, Inc. | 08/28/2009SE |
| K081527 | Light Diagnostics HSV 1/2 Typing Dfa KitGQL · Traditional | Millipore Corporation | 04/01/2009SE |
| K984135 | The Aptus (Automated) Application of the HSV-1 Igg Elisa Test System. an Enzyme Linked…GQL · Traditional | Zeus Scientific, Inc. | 05/26/1999SE |
| K984120 | The Aptus(Automated) Application of the HSV-2 Igg Elisa Test System. an Enzyme Linked…GQL · Traditional | Zeus Scientific, Inc. | 05/26/1999SE |
| K905608 | Indirect Fluorescent Assay for Herpes Simplex 1GQL · Traditional | Stellar Bio Systems, Inc. | 11/07/1991SE |
| K904095 | Herpes Simplex Virus Tissue Culture Conf. TypingGQL · Traditional | California Integrated Diagnostics, Inc. | 02/01/1991SE |
| K904167 | Pathodx Herpes TypingGQL · Traditional | Diagnostic Products Corp. | 12/13/1990SE |
| K902662 | Bartels Herpes Simplex Vir Flu Mono Antibody TestGQL · Traditional | Baxter Healthcare Corp | 07/31/1990SE |
| K902661 | Bartels Herpes Simplex Vir Flu Mono Antib HSV-1&2GQL · Traditional | Baxter Healthcare Corp | 07/31/1990SE |
| K891782 | HSV-2 Elisa Test SystemGQL · Traditional | Zeus Scientific, Inc. | 06/20/1989SE |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830971 | Herpes Simplex Virus Typing ReagentsGQL · Traditional | 06/30/1983SE |
| K830342 | Culuture Set Chlamydia Isolation andLKI · Traditional | 05/04/1983SE |
| K830250 | CVT Viral TransportsJTW · Traditional | 02/28/1983SE |
| K823304 | Riaset Prolactin Ria KitCFT · Traditional | 12/22/1982SE |
| K822785 | Fluoroset Immunofluorescent AntibodyGQL · Traditional | 11/29/1982SE |
| K823055 | Flouroset Immunofluorescent AntibodyDHN · Traditional | 11/05/1982SE |
| K822606 | Cytomegalovirus Antobody IggLIN · Traditional | 11/01/1982SE |
| K822605 | Toxoplasma Gondii Antibody IggLJK · Traditional | 10/27/1982SE |
| K822607 | Antinuclear Antobody Cell SubstrateDHN · Traditional | 09/17/1982SE |
| K821567 | Immulok CulturesetGQL · Traditional | 06/25/1982SE |
Questions and answers
When was Histoset Immunoperofidase Tissue cleared by the FDA?
Histoset Immunoperofidase Tissue (K821411) received a 510(k) decision of Substantially Equivalent on June 25, 1982, 44 days after the submission was received.
What is the product code of K821411?
The FDA product code is GQL – Antisera, Fluorescent, Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.