Mycoplasma Pneumoniae Antibody Eia Test System
FDA 510(k) K920212 · Shared Systems, Inc.
510(k) numberK920212
Submission
- Device name
- Mycoplasma Pneumoniae Antibody Eia Test System
- Applicant
- Shared Systems, Inc.
Martinez, GA, US - Received
- January 16, 1992
- Decision date
- August 20, 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 |
| 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 |
| K895276 | Diatech Igm-Mp TestLJZ · Traditional | Diatech Diagnostica , Ltd. | 12/18/1989SE |
More from Diatech Diagnostica , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K973457 | Chromalex E. Coli 0157 Latex Test System, Prod. No. 800GMZ · Traditional | 01/02/1998SE |
| K955042 | Chromalex C-Reactive Protein Latex Test SystemDCN · Traditional | 12/13/1995SE |
| K950073 | Mycoplasma Pneumoniae Antibody Latex Agglutination Test SystemGSA · Traditional | 10/17/1995SE |
| K953261 | Chromalex Rheumatoid Factor Latex Test SystemDHR · Traditional | 08/15/1995SE |
Questions and answers
When was Mycoplasma Pneumoniae Antibody Eia Test System cleared by the FDA?
Mycoplasma Pneumoniae Antibody Eia Test System (K920212) received a 510(k) decision of Substantially Equivalent on August 20, 1992, 217 days after the submission was received.
What is the product code of K920212?
The FDA product code is LJZ – Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.