Direct Elisa for Herpes Simplex Virus
FDA 510(k) K853307 · Fairleigh Dickinson Laboratories, Inc.
510(k) numberK853307
Submission
- Device name
- Direct Elisa for Herpes Simplex Virus
- Applicant
- Fairleigh Dickinson Laboratories, Inc.
Abilene, TX, US - Received
- August 7, 1985
- Decision date
- December 23, 1985
- 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 |
|---|---|---|
| K896032 | Modified Elisa for ChlamydiaLJC · Traditional | 01/29/1990SE |
| K895187 | FDL, Inc.'s Transport SystemJTW · Traditional | 10/24/1989SE |
| K883266 | FDL Elisa for ChlamydiaLJC · Traditional | 10/25/1988SE |
| K881502 | Brewer Gel for CampylobacterKZJ · Traditional | 04/27/1988SE |
| K875362 | Brewer Gel for AnaerobesKZJ · Traditional | 01/27/1988SE |
| K850251 | Rotalok Surgical Hand Table · Traditional | 02/28/1985SE |
Questions and answers
When was Direct Elisa for Herpes Simplex Virus cleared by the FDA?
Direct Elisa for Herpes Simplex Virus (K853307) received a 510(k) decision of Substantially Equivalent on December 23, 1985, 138 days after the submission was received.
What is the product code of K853307?
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.