HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G
FDA 510(k) K000238 · Mrl Diagnostics
510(k) numberK000238
Submission
- Device name
- HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G
- Applicant
- Mrl Diagnostics
Cypress, CA, US - Received
- January 27, 2000
- Decision date
- April 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K963645 | Herpes Group Igg Elisa Test SystemLGC · Traditional | Armkel, LLC | 02/04/1997SE |
More from Armkel, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K993754 | HSV-1 Elisa Igg, Model EL0910GMXJ · Traditional | 02/09/2000SE |
| K993724 | HSV-2 Elisa Igg, Model EL0920GMYF · Traditional | 02/01/2000SE |
| K971007 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (WB0400M)LSR · Traditional | 06/01/1998SE |
| K971006 | Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (WB0400G)LSR · Traditional | 06/01/1998SE |
| K946353 | Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent AssayLLM · Traditional | 07/21/1995SE |
| K931520 | Epstein-Barr Virus Vca (Igm) Recomb Immun AntibodyLJN · Traditional | 04/26/1994SE |
Questions and answers
When was HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G cleared by the FDA?
HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G (K000238) received a 510(k) decision of Substantially Equivalent on April 14, 2000, 78 days after the submission was received.
What is the product code of K000238?
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.