Chlamydia Microplate Eia, Chlamydia Microplae Eia Blocking Assay
FDA 510(k) K935393 · Bio-Rad Laboratories, Inc.
510(k) numberK935393
Submission
- Device name
- Chlamydia Microplate Eia, Chlamydia Microplae Eia Blocking Assay
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- November 8, 1993
- Decision date
- September 20, 1994
- 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
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|---|---|---|---|
| K032330 | CT OiaLJC · Traditional | Thermo Biostar, Inc. | 03/02/2004SE |
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| 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 Chlamydia Microplate Eia, Chlamydia Microplae Eia Blocking Assay cleared by the FDA?
Chlamydia Microplate Eia, Chlamydia Microplae Eia Blocking Assay (K935393) received a 510(k) decision of Substantially Equivalent on September 20, 1994, 316 days after the submission was received.
What is the product code of K935393?
The FDA product code is LJC – Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), a Class I (low risk) device regulated under 21 CFR 866.3120.