Immunowell Mycoplasma Pneumonia Antibody (Igg) Test 3120
FDA 510(k) K963055 · Genbio
510(k) numberK963055
Submission
- Device name
- Immunowell Mycoplasma Pneumonia Antibody (Igg) Test 3120
- Applicant
- Genbio
San Diego, CA, US - Received
- August 6, 1996
- Decision date
- May 2, 1997
- 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 |
| 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 |
| K895276 | Diatech Igm-Mp TestLJZ · Traditional | Diatech Diagnostica , Ltd. | 12/18/1989SE |
More from Diatech Diagnostica , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K010301 | Immunowell Ea (D) Igg TestLSE · Traditional | 06/11/2001SE |
| K974244 | Immunodot Mono-M TestLSE · Traditional | 09/22/1998SE |
| K974226 | Immunodot Mono-G TestLSE · Traditional | 09/22/1998SE |
| K973941 | Immunowell Ebna Igg TestLLM · Traditional | 08/10/1998SE |
| K973940 | Immunowell Ebv Vca Igg TestLSE · Traditional | 08/10/1998SE |
| K973939 | Immunowell Vca Igm TestLJN · Traditional | 08/10/1998SE |
| K963054 | Immunowell Mycoplasma Pneumonia Antibody (Igm) Test (3130)LJZ · Traditional | 05/05/1997SE |
| K953683 | Mmuno Dot Borrelia Dot Blot M TestLSR · Traditional | 05/03/1996SE |
| K953682 | Immuno Dot Borrelia Dot Blot G TestLSR · Traditional | 05/03/1996SE |
Questions and answers
When was Immunowell Mycoplasma Pneumonia Antibody (Igg) Test 3120 cleared by the FDA?
Immunowell Mycoplasma Pneumonia Antibody (Igg) Test 3120 (K963055) received a 510(k) decision of Substantially Equivalent on May 2, 1997, 269 days after the submission was received.
What is the product code of K963055?
The FDA product code is LJZ – Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.