MYCOPLASMA IGG ELISA TEST SYSTEM
FDA 510(k) clearance K970150 · decided 1997-06-16
Clearance details
- K-number
- K970150
- Device name
- MYCOPLASMA IGG ELISA TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-15
- Decision date
- 1997-06-16
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- LJZ
- Device class
- 1
- Regulation number
- 866.3375
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Raritan, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. (K984153) | Zeus Scientific, Inc. | 1999-01-11 |
| MYCOPLASMA IGM ELISA TEST SYSTEM (K971503) | Zeus Scientific, Inc. | 1997-08-20 |
| MYCOPLASMA IGG ELISA TEST SYSTEM (K971393) | Immunoprobe, Inc. | 1997-07-14 |
| IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) (K963054) | Genbio | 1997-05-05 |
| IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 (K963055) | Genbio | 1997-05-02 |
| IMMUNOCARD MYCOPLASMA (K934550) | Meridian Diagnostics, Inc. | 1994-09-20 |
| MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM (K920212) | Shared Systems, Inc. | 1992-08-20 |
| MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM (K921556) | Medical Diagnostic Technologies, Inc. | 1992-06-29 |
| MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM (K904501) | Medical Diagnostic Technologies, Inc. | 1991-02-26 |
| DIATECH IGM-MP TEST (K895276) | Diatech Diagnostica , Ltd. | 1989-12-18 |
| MP TEST (K882596) | Diatech Diagnostica , Ltd. | 1989-06-21 |
| MYCOPLASMELISA TEST KIT (K823804) | M.A. Bioproducts | 1983-05-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042) | Zeus Scientific, Inc. | 2017-09-19 |
| ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045) | Zeus Scientific, Inc. | 2017-09-19 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S001) | Zeus Scientific, Inc. | 1992-04-21 |
| FLUORO-CEP (R) PROGESTERONE (P900025/S002) | Zeus Scientific, Inc. | 1992-04-17 |
| FLUORO-CEP (R) PROGESTERONE (P900025) | Zeus Scientific, Inc. | 1990-09-26 |