Serocard HSV Igg Antibody Test Kit
FDA 510(k) K903070 · Disease Detection International, Inc.
510(k) numberK903070
Submission
- Device name
- Serocard HSV Igg Antibody Test Kit
- Applicant
- Disease Detection International, Inc.
Irvine, CA, US - Received
- July 12, 1990
- Decision date
- August 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LGC – Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
Other 510(k)s with product code LGC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K033059 | Herpes Group IggLGC · Traditional | Trinity Biotech, Inc. | 11/26/2003SE |
| K010878 | Modification to Immulite Herpes I & II Igg, Model L2KHS2 & L2KHS6LGC · Special | Diagnostic Products Corp. | 04/18/2001SE |
| K002262 | Diamedix Is-Hsv 1&2 Igm Test SystemLGC · Traditional | Diamedix Corp. | 11/28/2000SE |
| K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GLGC · Traditional | Mrl Diagnostics | 04/14/2000SE |
| K992166 | The Aptus (Automated) Application of the HSV 1/2 Igm Elisa Test System. an Enzyme Linked…LGC · Traditional | Zeus Scientific, Inc. | 09/03/1999SE |
| K983886 | Pockit HSV 2 Rapid TestLGC · Traditional | Diagnology , Ltd. | 08/19/1999SE |
| K984346 | Premier Type Specific HSV-2 Igg Elisa TestLGC · Traditional | Meridian Diagnostics, Inc. | 06/25/1999SE |
| K983656 | HSV-1 And/Or -2 Igm Elisa Test SystemLGC · Traditional | Zeus Scientific, Inc. | 03/18/1999SE |
| K983541 | HSV 1+2 Igg Elisa TestLGC · Traditional | Gull Laboratories, Inc. | 02/26/1999SE |
| K981306 | Diamedix Is-Hsv 1 & 2 Igg Test SystemLGC · Traditional | Diamedix Corp. | 09/29/1998SE |
More from Diamedix Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K943252 | Pro-Step LH Ovulation Prediction TestCEP · Traditional | 10/25/1994SE |
| K925303 | Pro-Step PT HCGJHI · Traditional | 06/15/1993SE |
| K925125 | Pro-Step HCGJHI · Traditional | 01/13/1993SE |
| K911826 | Immunocard HCG One Step (I-S) Test KitJHI · Traditional | 07/19/1991SE |
| K902571 | Modification of Serocard Rubella Igg TestLFX · Traditional | 09/05/1990SE |
| K895912 | Immunocard HCG Ii-S Test KitJHI · Traditional | 12/01/1989SE |
| K896109 | Immunocard Strep a TestGTZ · Traditional | 11/29/1989SE |
| K884249 | Modified Ddi Serocard Toxoplasma Igg Test KitLGD · Traditional | 04/10/1989SE |
| K884248 | Modified Ddi Serocard CMV Igg Test KitLFZ · Traditional | 04/10/1989SE |
| K884247 | Modified Ddi Serocard Rubella Igg Test KitLFX · Traditional | 04/10/1989SE |
Questions and answers
When was Serocard HSV Igg Antibody Test Kit cleared by the FDA?
Serocard HSV Igg Antibody Test Kit (K903070) received a 510(k) decision of Substantially Equivalent on August 9, 1990, 28 days after the submission was received.
What is the product code of K903070?
The FDA product code is LGC – Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific, a Class II (moderate risk) device regulated under 21 CFR 866.3305.