Mycoplasmelisa Test Kit
FDA 510(k) K823804 · M.A. Bioproducts
510(k) numberK823804
Submission
- Device name
- Mycoplasmelisa Test Kit
- Applicant
- M.A. Bioproducts
Walker, MI, US - Received
- December 17, 1982
- Decision date
- May 25, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJZ – Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3375
- Specialty
- Microbiology
Other 510(k)s with product code LJZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984153 | The Aptus (Automated) Application of the Mycoplasma Igm Elisa Test System.LJZ · Traditional | Zeus Scientific, Inc. | 01/11/1999SE |
| K971503 | Mycoplasma Igm Elisa Test SystemLJZ · Traditional | Zeus Scientific, Inc. | 08/20/1997SE |
| K971393 | Mycoplasma Igg Elisa Test SystemLJZ · Traditional | Immunoprobe, Inc. | 07/14/1997SE |
| K970150 | Mycoplasma Igg Elisa Test SystemLJZ · Traditional | Zeus Scientific, Inc. | 06/16/1997SE |
| K963054 | Immunowell Mycoplasma Pneumonia Antibody (Igm) Test (3130)LJZ · Traditional | Genbio | 05/05/1997SE |
| K963055 | Immunowell Mycoplasma Pneumonia Antibody (Igg) Test 3120LJZ · Traditional | Genbio | 05/02/1997SE |
| K934550 | Immunocard MycoplasmaLJZ · Traditional | Meridian Diagnostics, Inc. | 09/20/1994SE |
| K920212 | Mycoplasma Pneumoniae Antibody Eia Test SystemLJZ · Traditional | Shared Systems, Inc. | 08/20/1992SE |
| K921556 | Mycoplasma Pneumoniae Igg/Igm Antibody Test SystemLJZ · Traditional | Medical Diagnostic Technologies, Inc. | 06/29/1992SE |
| K904501 | Mycoplasma Pneumoniae Antibody Test SystemLJZ · Traditional | Medical Diagnostic Technologies, Inc. | 02/26/1991SE |
More from Medical Diagnostic Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822883 | Herpelisa KitLGC · Traditional | 07/26/1983SE |
| K830045 | Mumpselisa Test KitLJY · Traditional | 05/13/1983SE |
| K830615 | Cytomegelisa StatLFZ · Traditional | 05/09/1983SE |
| K823805 | Varicelisa Test KitLFY · Traditional | 05/05/1983SE |
| K821967 | Chlamydelisa Test KitLJC · Traditional | 08/03/1982SE |
| 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 Mycoplasmelisa Test Kit cleared by the FDA?
Mycoplasmelisa Test Kit (K823804) received a 510(k) decision of Substantially Equivalent on May 25, 1983, 159 days after the submission was received.
What is the product code of K823804?
The FDA product code is LJZ – Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.