The Aptus(Automated) Application of the HSV-2 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH
FDA 510(k) K984120 · Zeus Scientific, Inc.
510(k) numberK984120
Submission
- Device name
- The Aptus(Automated) Application of the HSV-2 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- November 18, 1998
- Decision date
- May 26, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GQL – Antisera, Fluorescent, Herpesvirus Hominis 1,2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code GQL
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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 |
| 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 |
| K891162 | HSV-1 Elisa Test SystemGQL · Traditional | Zeus Scientific, Inc. | 06/20/1989SE |
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Questions and answers
When was The Aptus(Automated) Application of the HSV-2 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH cleared by the FDA?
The Aptus(Automated) Application of the HSV-2 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) for TH (K984120) received a 510(k) decision of Substantially Equivalent on May 26, 1999, 189 days after the submission was received.
What is the product code of K984120?
The FDA product code is GQL – Antisera, Fluorescent, Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.