Panels › Microbiology › Product code LJZ · Class 1
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Regulation 866.3375
0510(k)s in 12 months (13 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in LJZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Calbiotech Inc | 0 | 3 |
| Zeus Scientific, Inc. | 3 | 0 |
| Diatech Diagnostica , Ltd. | 2 | 0 |
| Genbio | 2 | 0 |
| Medical Diagnostic Technologies, Inc. | 2 | 0 |
| Immunoprobe, Inc. | 1 | 0 |
| M.A. Bioproducts | 1 | 0 |
| Meridian Bioscience Inc | 0 | 1 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Shared Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 1999 | K984153 | THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. Zeus Scientific, Inc. | LJZ |
| Aug 20, 1997 | K971503 | MYCOPLASMA IGM ELISA TEST SYSTEM Zeus Scientific, Inc. | LJZ |
| Jul 14, 1997 | K971393 | MYCOPLASMA IGG ELISA TEST SYSTEM Immunoprobe, Inc. | LJZ |
| Jun 16, 1997 | K970150 | MYCOPLASMA IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | LJZ |
| May 5, 1997 | K963054 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) Genbio | LJZ |
| May 2, 1997 | K963055 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 Genbio | LJZ |
| Sep 20, 1994 | K934550 | IMMUNOCARD MYCOPLASMA Meridian Diagnostics, Inc. | LJZ |
| Aug 20, 1992 | K920212 | MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM Shared Systems, Inc. | LJZ |
| Jun 29, 1992 | K921556 | MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM Medical Diagnostic Technologies, Inc. | LJZ |
| Feb 26, 1991 | K904501 | MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM Medical Diagnostic Technologies, Inc. | LJZ |
| Dec 18, 1989 | K895276 | DIATECH IGM-MP TEST Diatech Diagnostica , Ltd., IL | LJZ |
| Jun 21, 1989 | K882596 | MP TEST Diatech Diagnostica , Ltd. | LJZ |
| May 25, 1983 | K823804 | MYCOPLASMELISA TEST KIT M.A. Bioproducts | LJZ |
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