Ramp Herpes Simplex Virus (HSV) (CCT)
FDA 510(k) K874863 · Monoclonal Antibodies, Inc.
510(k) numberK874863
Submission
- Device name
- Ramp Herpes Simplex Virus (HSV) (CCT)
- Applicant
- Monoclonal Antibodies, Inc.
Sunnyvale, CA, US - Received
- November 25, 1987
- Decision date
- February 16, 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 |
|---|---|---|
| K871726 | Ovuquick Self-Test (Ovuquick; Ramp LH Assay)CEP · Traditional | 07/27/1987SE |
| K863744 | HCG Control KitJJX · Traditional | 11/05/1986SE |
| K860924 | Ramp Progesturine PDG ASSAY--48 Test KitJLS · Traditional | 07/02/1986SE |
| K854611 | Ramp Urine HCG AssayJHI · Traditional | 12/30/1985SE |
| K850730 | Model Serum HCG AssayJHI · Traditional | 04/02/1985SE |
| K850480 | Ovu Stick Self-Test -ModificationCEP · Traditional | 03/05/1985SE |
| K843284 | Ovustick Self-TestCEP · Traditional | 12/11/1984SE |
| K840738 | Plus Urine HCG AssayJHJ · Traditional | 04/19/1984SE |
| K840412 | Ovu Stick Urine HLH KitCEP · Traditional | 04/13/1984SE |
| K833504 | Pregnastick Urine HCG KitJHJ · Traditional | 01/09/1984SE |
Questions and answers
When was Ramp Herpes Simplex Virus (HSV) (CCT) cleared by the FDA?
Ramp Herpes Simplex Virus (HSV) (CCT) (K874863) received a 510(k) decision of Substantially Equivalent on February 16, 1988, 83 days after the submission was received.
What is the product code of K874863?
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.