Chlamydia Igg Elisa Test System
FDA 510(k) K033079 · Trinity Biotech USA
510(k) numberK033079
Submission
- Device name
- Chlamydia Igg Elisa Test System
- Applicant
- Trinity Biotech USA
Jamestown, NY, US - Received
- September 29, 2003
- Decision date
- November 26, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Specialty
- Microbiology
Other 510(k)s with product code LJC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032330 | CT OiaLJC · Traditional | Thermo Biostar, Inc. | 03/02/2004SE |
| K033865 | Ideia Pce ChlamydiaLJC · Special | Dakocytomation, Ltd. | 01/21/2004SE |
| K982210 | Modification of Syva Microtrak II Chlamydia EiaLJC · Special | Dade Behring, Inc. | 07/09/1998SE |
| K962558 | Chlamydia Igg Elisa Test SystemLJC · Traditional | Armkel, LLC | 02/24/1997SE |
| K960850 | Access Chlamydia AssayLJC · Traditional | Bio-Rad Laboratories, Inc. | 02/04/1997SE |
| K955627 | Vidas Chlamydia Blocking AssayLJC · Traditional | Biomerieux Vitek, Inc. | 10/07/1996SE |
| K936054 | Imx Select ChlamydiaLJC · Traditional | Abbott Laboratories | 05/30/1996SE |
| K940564 | Ideia(Tm) Chlamydia Blocking Reagents, ModificationLJC · Traditional | Dako Diagnostics , Ltd. | 01/11/1996SE |
| K951010 | Chlamydia OiaLJC · Traditional | Biostar, Inc. | 10/07/1995SE |
| K946276 | Quickvue(R) Chlamydia TestLJC · Traditional | Quidel Corp. | 05/19/1995SE |
More from Quidel Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K140455 | Captia Measles IgmPCL · Traditional | 05/22/2014SE |
| K033106 | Captia HSV 2 Igg Type Specific Elisa KitMYF · Traditional | 07/13/2004SE |
| K033105 | Captia HSV 1 Igg Type Specific Elisa KitMXJ · Traditional | 07/13/2004SE |
| K033083 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 11/26/2003SE |
| K033070 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | 11/26/2003SE |
| K033067 | Pylori IggLYR · Traditional | 11/26/2003SE |
| K033064 | Mycoplasma IggLON · Traditional | 11/26/2003SE |
| K033051 | Legionella Pneumophila Igg/IgmMJH · Traditional | 11/26/2003SE |
| K993839 | Ena Profile Elisa Test SystemLLL · Traditional | 01/12/2000SE |
| K992665 | Macra Lp(A) Enzyme Immunoassay KitDFC · Traditional | 11/26/1999SE |
Questions and answers
When was Chlamydia Igg Elisa Test System cleared by the FDA?
Chlamydia Igg Elisa Test System (K033079) received a 510(k) decision of Substantially Equivalent on November 26, 2003, 58 days after the submission was received.
What is the product code of K033079?
The FDA product code is LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), a Class I (low risk) device regulated under 21 CFR 866.3120.