Mycoplasma Pneumoniae Igg/Igm Antibody Test System
FDA 510(k) K921556 · Medical Diagnostic Technologies, Inc.
510(k) numberK921556
Submission
- Device name
- Mycoplasma Pneumoniae Igg/Igm Antibody Test System
- Applicant
- Medical Diagnostic Technologies, Inc.
Augusta, GA, US - Received
- April 1, 1992
- Decision date
- June 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K904501 | Mycoplasma Pneumoniae Antibody Test SystemLJZ · Traditional | Medical Diagnostic Technologies, Inc. | 02/26/1991SE |
| K895276 | Diatech Igm-Mp TestLJZ · Traditional | Diatech Diagnostica , Ltd. | 12/18/1989SE |
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| K961724 | U-Doa ControlsDIF · Traditional | 06/03/1996SE |
| K961370 | La Positive Control PlasmaGGC · Traditional | 05/24/1996SE |
| K955115 | Venom Tiem ReagentJCO · Traditional | 04/03/1996SE |
| K955738 | Bioclot Protein SGGP · Traditional | 02/29/1996SE |
Questions and answers
When was Mycoplasma Pneumoniae Igg/Igm Antibody Test System cleared by the FDA?
Mycoplasma Pneumoniae Igg/Igm Antibody Test System (K921556) received a 510(k) decision of Substantially Equivalent on June 29, 1992, 89 days after the submission was received.
What is the product code of K921556?
The FDA product code is LJZ – Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.