Chlamyset Antibody Eia
FDA 510(k) K864457 · Orion Corp.
510(k) numberK864457
Submission
- Device name
- Chlamyset Antibody Eia
- Applicant
- Orion Corp.
20101 Turku, FI - Received
- November 12, 1986
- Decision date
- September 11, 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 |
More from Biostar, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K912391 | Rubalex, ModificationLQN · Traditional | 05/04/1992SE |
| K901637 | Resubmitted Modified RubalexLQN · Traditional | 04/26/1990SE |
| K884650 | Resubmitted ScanoraIZF · Traditional | 03/16/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | 03/02/1989SE |
| K881506 | Mamex DC Mag MG12IZH · Traditional | 06/10/1988SE |
| K881505 | Mamex DC MG11IZH · Traditional | 06/10/1988SE |
| K874040 | Mamex DC S SL10/MG14IZH · Traditional | 11/23/1987SE |
| K872744 | Modified Chlamyset AntigenLJP · Traditional | 09/22/1987SE |
| K872301 | Dentocult-Sm Culture-PaddleJSI · Traditional | 09/11/1987SE |
| K872058 | Oricult-N Culture-PaddleJSI · Traditional | 06/10/1987SE |
Questions and answers
When was Chlamyset Antibody Eia cleared by the FDA?
Chlamyset Antibody Eia (K864457) received a 510(k) decision of Substantially Equivalent on September 11, 1987, 303 days after the submission was received.
What is the product code of K864457?
The FDA product code is LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), a Class I (low risk) device regulated under 21 CFR 866.3120.