ZEUA MYCOPLASMA
FDA 510(k) clearance K944417 · decided 1995-08-01
Clearance details
- K-number
- K944417
- Device name
- ZEUA MYCOPLASMA
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-06
- Decision date
- 1995-08-01
- Days to decision
- 329 days
- Clearance type
- Traditional
- Product code
- GRZ
- 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 |
|---|---|---|
| MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM (K946373) | Zeus Scientific, Inc. | 1996-02-07 |
| FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST (K931557) | Fuller Laboratories, Inc. | 1994-03-11 |
| FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY (K861716) | Whittaker Bioproducts, Inc. | 1986-08-08 |
| INDIRECT FLUORESCENT ANTIBODY MYCO (K840012) | Zeus Technologies | 1984-02-27 |
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 |