Herpes Simplex Antibody Test for Dect. of HSV 1&2
FDA 510(k) K870814 · Microscan Div. Baxter Healthcare Corp.
510(k) numberK870814
Submission
- Device name
- Herpes Simplex Antibody Test for Dect. of HSV 1&2
- Applicant
- Microscan Div. Baxter Healthcare Corp.
West Sacramento, CA, US - Received
- March 3, 1987
- Decision date
- June 4, 1987
- 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
Other 510(k)s with product code GQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K871234 | Antibody Assay for Detect. of Parainfluenza Type 1GQS · Traditional | 06/26/1987SE |
| K871233 | Antibody Assay for Detection of Influenza aGNX · Traditional | 06/26/1987SE |
| K871232 | Antibody Assay for Detect. of Parainfluenza Type 3GQS · Traditional | 06/26/1987SE |
| K871231 | Antibody Assay for Detection of Influenza BGNX · Traditional | 06/26/1987SE |
| K871230 | Antibody Assay for Detec. of Resp. Syncytial VirusLKT · Traditional | 06/26/1987SE |
| K871229 | Antibody Assay for Detection of Adenovirus in CellGOD · Traditional | 06/26/1987SE |
| K871228 | Antibody Assay for Detect. of Parainfluenza Type 2GQS · Traditional | 06/26/1987SE |
| K870074 | Gram Negative and Gram Positive Mic/Combo PanelsJWY · Traditional | 04/14/1987SE |
| K871033 | Rabbit Kidney Culture Cells (First Pass)KIR · Traditional | 03/31/1987SE |
| K870089 | Immunoscan(Tm) Direct Neisseria Meningitidis KitGTJ · Traditional | 03/17/1987SE |
Questions and answers
When was Herpes Simplex Antibody Test for Dect. of HSV 1&2 cleared by the FDA?
Herpes Simplex Antibody Test for Dect. of HSV 1&2 (K870814) received a 510(k) decision of Substantially Equivalent on June 4, 1987, 93 days after the submission was received.
What is the product code of K870814?
The FDA product code is GQL – Antisera, Fluorescent, Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.