ENA PROFILE-6 ELISA TEST SYSTEM
FDA 510(k) clearance K941409 · decided 1994-06-10
Clearance details
- K-number
- K941409
- Device name
- ENA PROFILE-6 ELISA TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-23
- Decision date
- 1994-06-10
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- LJM
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Raritan, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-L recall (Z-1089-2009) | Zeus Scientific Inc | 2009-03-31 |
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|---|---|---|
| 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 |
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