Visible-Herpes TM Test System
FDA 510(k) K854712 · Isolab, Inc.
510(k) numberK854712
Submission
- Device name
- Visible-Herpes TM Test System
- Applicant
- Isolab, Inc.
Akron, OH, US - Received
- November 22, 1985
- Decision date
- May 20, 1986
- 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 |
| 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 |
| K842531 | Amizyme-Hsv Types 1 & 2 Test KitsGQO · Traditional | Amico Lab, Inc. | 12/06/1985SE |
More from Amico Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | 02/01/1996SE |
| K943547 | Phenylalanine Test KitJNB · Traditional | 01/26/1996SE |
| K950803 | Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional | 09/21/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | 09/05/1995SE |
| K942276 | Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional | 01/20/1995SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
| K944185 | IsoscanJQT · Traditional | 11/17/1994SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | 04/26/1994SE |
| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
Questions and answers
When was Visible-Herpes TM Test System cleared by the FDA?
Visible-Herpes TM Test System (K854712) received a 510(k) decision of Substantially Equivalent on May 20, 1986, 179 days after the submission was received.
What is the product code of K854712?
The FDA product code is GQO – Antisera, Cf, Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.