CT Oia
FDA 510(k) K032330 · Thermo Biostar, Inc.
510(k) numberK032330
Submission
- Device name
- CT Oia
- Applicant
- Thermo Biostar, Inc.
Louisville, CO, US - Received
- July 29, 2003
- Decision date
- March 2, 2004
- 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 |
|---|---|---|---|
| K033865 | Ideia Pce ChlamydiaLJC · Special | Dakocytomation, Ltd. | 01/21/2004SE |
| K033079 | Chlamydia Igg Elisa Test SystemLJC · Traditional | Trinity Biotech USA | 11/26/2003SE |
| 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.
Questions and answers
When was CT Oia cleared by the FDA?
CT Oia (K032330) received a 510(k) decision of Substantially Equivalent on March 2, 2004, 217 days after the submission was received.
What is the product code of K032330?
The FDA product code is LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), a Class I (low risk) device regulated under 21 CFR 866.3120.