510(k) K921556
- Device
- MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM
- Applicant
- MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
- 510(k) number
- K921556
- Product code
- LJZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-06-29
- Date received
- 1992-04-01
- Regulation
- 866.3375
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID A WALL
- Address
- 3351 Wrightsboro Rd. Suite 502 Augusta GA US 30909 30909
FDA Registration Numbers#
- 3003750284
- 3002800697
- 3007361513
- 3008191245
- 3003268355
- 1318354
- 8030124
- 1924669
- 2242436
- 2029372
- 2245285
- 1524213
- 2027113
- 3007118747
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LJZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K984153 | THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. | Zeus Scientific, Inc. | 1999-01-11 |
| K971503 | MYCOPLASMA IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-08-20 |
| K971393 | MYCOPLASMA IGG ELISA TEST SYSTEM | Immunoprobe, Inc. | 1997-07-14 |
| K970150 | MYCOPLASMA IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-06-16 |
| K963054 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) | Genbio | 1997-05-05 |
| K963055 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 | Genbio | 1997-05-02 |
| K934550 | IMMUNOCARD MYCOPLASMA | Meridian Diagnostics, Inc. | 1994-09-20 |
| K920212 | MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM | Shared Systems, Inc. | 1992-08-20 |
| K904501 | MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1991-02-26 |
| K895276 | DIATECH IGM-MP TEST | Diatech Diagnostica , Ltd. | 1989-12-18 |
| K882596 | MP TEST | Diatech Diagnostica , Ltd. | 1989-06-21 |
| K823804 | MYCOPLASMELISA TEST KIT | M.A. Bioproducts | 1983-05-25 |
Legacy Summary#
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FDA Review#
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