HSV Bio-Bead Screen Kit
FDA 510(k) K791614 · Litton Bionetics
510(k) numberK791614
Submission
- Device name
- HSV Bio-Bead Screen Kit
- Applicant
- Litton Bionetics
Mchenry, IL, US - Received
- August 21, 1979
- Decision date
- November 13, 1979
- 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 |
|---|---|---|
| K840417 | Ebna Acif KitLLM · Traditional | 12/27/1984SE |
| K834443 | Rotavirus Bio-Enzabead Screen KitLIQ · Traditional | 03/16/1984SE |
| K831343 | CMV RQ Bio-Enzabead KitLFZ · Traditional | 08/08/1983SE |
| K822985 | Ebv-M KitJRY · Traditional | 12/03/1982SE |
| K821804 | Rubella RQ Bio-Enzabead KitLFX · Traditional | 09/14/1982SE |
| K801722 | CMV Bio-Bead Titration KitGQH · Traditional | 09/16/1980SE |
| K801721 | HSV Bio-Bead Titration KitGQN · Traditional | 09/16/1980SE |
| K801720 | Toxo Bio-Bead Titration KitGLZ · Traditional | 09/16/1980SE |
| K800789 | Rubella Bio-Bead Titration KitGOL · Traditional | 06/30/1980SE |
| K791618 | Torch Bio-Bead Screen KitGLZ · Traditional | 11/13/1979SE |
Questions and answers
When was HSV Bio-Bead Screen Kit cleared by the FDA?
HSV Bio-Bead Screen Kit (K791614) received a 510(k) decision of Substantially Equivalent on November 13, 1979, 84 days after the submission was received.
What is the product code of K791614?
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.