Chlamydelisa Test Kit
FDA 510(k) K821967 · M.A. Bioproducts
510(k) numberK821967
Submission
- Device name
- Chlamydelisa Test Kit
- Applicant
- M.A. Bioproducts
Mchenry, IL, US - Received
- July 2, 1982
- Decision date
- August 3, 1982
- 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 |
More from Biostar, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822883 | Herpelisa KitLGC · Traditional | 07/26/1983SE |
| K823804 | Mycoplasmelisa Test KitLJZ · Traditional | 05/25/1983SE |
| K830045 | Mumpselisa Test KitLJY · Traditional | 05/13/1983SE |
| K830615 | Cytomegelisa StatLFZ · Traditional | 05/09/1983SE |
| K823805 | Varicelisa Test KitLFY · Traditional | 05/05/1983SE |
| K821762 | Measelisa Test KitLJB · Traditional | 07/30/1982SE |
| K813221 | Toxoelisa Test KitLGD · Traditional | 01/26/1982SE |
| K812531 | Cell Culture ReagentsKIT · Traditional | 10/23/1981SE |
| K812123 | Cytomegelisa Test Kit · Traditional | 09/23/1981SE |
| K802508 | Rubelisa Igm Test KitGOL · Traditional | 12/18/1980SE |
Questions and answers
When was Chlamydelisa Test Kit cleared by the FDA?
Chlamydelisa Test Kit (K821967) received a 510(k) decision of Substantially Equivalent on August 3, 1982, 32 days after the submission was received.
What is the product code of K821967?
The FDA product code is LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), a Class I (low risk) device regulated under 21 CFR 866.3120.