Bartels Herpes Simplex Virus 2 Igg Eia
FDA 510(k) K922583 · Baxter Diagnostics, Inc.
510(k) numberK922583
Submission
- Device name
- Bartels Herpes Simplex Virus 2 Igg Eia
- Applicant
- Baxter Diagnostics, Inc.
Bellevue, WA, US - Received
- May 27, 1992
- Decision date
- September 28, 1992
- 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 |
| 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 |
|---|---|---|
| K934458 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 07/18/1995SE |
| K950817 | Dried Gram Positive Mic/Combo Panels/PneumococciJWY · Traditional | 04/25/1995SE |
| K935704 | Dried Gram-Negative Mic//Combo PanelsLTT · Traditional | 04/14/1995SE |
| K950570 | Stratus Progesterone Fluorometric Enzyme ImmunoassayJLS · Traditional | 04/11/1995SE |
| K945235 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | 03/07/1995SE |
| K941030 | Dried Gram-Negative CefpodoximeLTT · Traditional | 02/16/1995SE |
| K940917 | Loracarbef Gram-Nagative PanelsJWY · Traditional | 02/08/1995SE |
| K941459 | Gram Positive Dried Overnight Panels/LomefloxJWY · Traditional | 02/03/1995SE |
| K941317 | Dried Gram Negative/CefmetazoleJWY · Traditional | 01/31/1995SE |
| K942267 | Dried Gram-Positive Mic/Combo Panels/CefmetazoleJWY · Traditional | 01/09/1995SE |
Questions and answers
When was Bartels Herpes Simplex Virus 2 Igg Eia cleared by the FDA?
Bartels Herpes Simplex Virus 2 Igg Eia (K922583) received a 510(k) decision of Substantially Equivalent on September 28, 1992, 124 days after the submission was received.
What is the product code of K922583?
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.