Virogen Herpes Slide Test
FDA 510(k) K852928 · Armkel, LLC
510(k) numberK852928
Submission
- Device name
- Virogen Herpes Slide Test
- Applicant
- Armkel, LLC
Cranbury, NJ, US - Received
- July 9, 1985
- Decision date
- October 17, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQO – Antisera, Cf, Herpesvirus Hominis 1,2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code GQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883282 | Virgo HSV-1 Igg ElisaGQO · Traditional | Electro-Nucleonics, Inc. | 03/10/1989SE |
| K883281 | Virgo HSV-2 Igg ElisaGQO · Traditional | Electro-Nucleonics, Inc. | 03/10/1989SE |
| K881261 | Bion HSV1-G or HSV2-G Test SystemGQO · Traditional | Bion Ent., Ltd. | 06/07/1988SE |
| K875366 | The Ddi Serodot Herpes Igg Test KitGQO · Traditional | Disease Detection International, Inc. | 05/23/1988SE |
| K871426 | Virogen HSV Antibody TestGQO · Traditional | Armkel, LLC | 10/15/1987SE |
| K861120 | The Golden Quad Test (HSV)GQO · Traditional | Microbiological Research Corp. | 02/02/1987SE |
| K854712 | Visible-Herpes TM Test SystemGQO · Traditional | Isolab, Inc. | 05/20/1986SE |
| K852782 | Hsvi - Igg Elisa-KitGQO · Traditional | Clinical Sciences, Inc. | 01/21/1986SE |
| K852781 | HSV2 - Igg Elisa-KitGQO · Traditional | Clinical Sciences, Inc. | 01/21/1986SE |
| K842663 | Anti-Herpes Simplex Virus Type 1 or 2GQO · Traditional | Amico Lab, Inc. | 12/06/1985SE |
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| K013433 | Trojan Passion Berry GelNUC · Traditional | 03/05/2002SE |
| K013614 | Trojan Crystal Clear LiquidNUC · Traditional | 02/01/2002SE |
| K001212 | Trojan Extra Large Latex CondomHIS · Special | 05/09/2000SE |
| K000748 | Trojan Latex Condom with Male Genital Desensitizer LubricantHIS · Special | 04/06/2000SE |
| K992232 | First Response 1-STEP PregnancyLCX · Traditional | 12/21/1999SE |
| K973352 | Brand Name *1-STEP PregnancyLCX · Traditional | 10/27/1997SE |
| K973310 | Tbd* One-Step Ovulation Predictor TestCEP · Traditional | 10/27/1997SE |
Questions and answers
When was Virogen Herpes Slide Test cleared by the FDA?
Virogen Herpes Slide Test (K852928) received a 510(k) decision of Substantially Equivalent on October 17, 1985, 100 days after the submission was received.
What is the product code of K852928?
The FDA product code is GQO – Antisera, Cf, Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.