Mycoplasma Igg Elisa Test System
FDA 510(k) K970150 · Zeus Scientific, Inc.
510(k) numberK970150
Submission
- Device name
- Mycoplasma Igg Elisa Test System
- Applicant
- Zeus Scientific, Inc.
Raritan, NJ, US - Received
- January 15, 1997
- Decision date
- June 16, 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 |
| 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 |
| K895276 | Diatech Igm-Mp TestLJZ · Traditional | Diatech Diagnostica , Ltd. | 12/18/1989SE |
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Questions and answers
When was Mycoplasma Igg Elisa Test System cleared by the FDA?
Mycoplasma Igg Elisa Test System (K970150) received a 510(k) decision of Substantially Equivalent on June 16, 1997, 152 days after the submission was received.
What is the product code of K970150?
The FDA product code is LJZ – Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.