Herpes Virus Control Slides
FDA 510(k) K883684 · Val Tech Diagnostics, Inc.
510(k) numberK883684
Submission
- Device name
- Herpes Virus Control Slides
- Applicant
- Val Tech Diagnostics, Inc.
Pittsburgh, PA, US - Received
- August 29, 1988
- Decision date
- September 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQN – Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code GQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070265 | Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit, Model…GQN · Traditional | Diagnostic Hybrids, Inc. | 10/24/2007SE |
| K063798 | Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model 01-080000GQN · Traditional | Diagnostic Hybrids, Inc. | 09/21/2007SE |
| K991880 | Light Diagnostics Simulfluor HSV 1/2 Immunofluorecence AssayGQN · Traditional | Light Diagnostics | 11/09/1999SE |
| K971662 | Elvis HSV Id/Typing Test SystemGQN · Traditional | Diagnostic Hybrids, Inc. | 11/18/1997SE |
| K971101 | HSV-2 Antigen Control SlidesGQN · Traditional | Viral Antigens, Inc. | 07/01/1997SE |
| K964874 | HSV-1 Antigen Control SlidesGQN · Traditional | Viral Antigens, Inc. | 07/01/1997SE |
| K960578 | Elvis HSV GoldGQN · Traditional | Diagnostic Hybrids, Inc. | 09/05/1996SE |
| K941924 | Elvis HSVGQN · Traditional | Diagnostic Hybrids, Inc. | 05/01/1995SE |
| K911345 | HSV in Situ DNA Probe Hybridization Test KitGQN · Traditional | Diagnostic Hybrids, Inc. | 06/17/1991SE |
| K884761 | Modified Cell-Matics Herpes Simplex Virus Detect.GQN · Traditional | Difco Laboratories, Inc. | 12/05/1988SE |
More from Difco Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883571 | Histo-Check Parasitic Control SlidesLJG · Traditional | 10/06/1988SE |
| K883570 | Histo-Check Fungal Control SlidesLJG · Traditional | 10/06/1988SE |
| K883569 | Histo-Check Gram Negative SlidesLJG · Traditional | 10/06/1988SE |
| K883568 | Histo-Check Acid Fast SlidesLJG · Traditional | 10/06/1988SE |
| K883567 | Histo-Check Legionella Control SlidesLJG · Traditional | 10/06/1988SE |
| K883232 | Histone Reactive AnaLLL · Traditional | 09/07/1988SE |
| K883208 | Histo-Check SlidesLJG · Traditional | 08/25/1988SE |
| K871395 | Dual Substrate AnaDHN · Traditional | 04/20/1987SE |
| K864668 | Ana Test KitLKJ · Traditional | 03/12/1987SE |
| K870732 | Rat Liver Nuclei Test SystemDHN · Traditional | 03/10/1987SE |
Questions and answers
When was Herpes Virus Control Slides cleared by the FDA?
Herpes Virus Control Slides (K883684) received a 510(k) decision of Substantially Equivalent on September 28, 1988, 30 days after the submission was received.
What is the product code of K883684?
The FDA product code is GQN – Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.