Immulite Herpes I and II Igg
FDA 510(k) K950670 · Diagnostic Products Corp.
510(k) numberK950670
Submission
- Device name
- Immulite Herpes I and II Igg
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- February 13, 1995
- Decision date
- June 21, 1996
- 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 |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite Herpes I and II Igg cleared by the FDA?
Immulite Herpes I and II Igg (K950670) received a 510(k) decision of Substantially Equivalent on June 21, 1996, 494 days after the submission was received.
What is the product code of K950670?
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.