Chlamydiazyme Diagnostic Kit
FDA 510(k) K864842 · Abbott Laboratories
510(k) numberK864842
Submission
- Device name
- Chlamydiazyme Diagnostic Kit
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- December 10, 1986
- Decision date
- April 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
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Questions and answers
When was Chlamydiazyme Diagnostic Kit cleared by the FDA?
Chlamydiazyme Diagnostic Kit (K864842) received a 510(k) decision of Substantially Equivalent on April 29, 1987, 140 days after the submission was received.
What is the product code of K864842?
The FDA product code is LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), a Class I (low risk) device regulated under 21 CFR 866.3120.