ATHENA MULTI-LYTE ANA-II TEST SYSTEM
FDA 510(k) clearance K042416 · decided 2004-10-08
Clearance details
- K-number
- K042416
- Device name
- ATHENA MULTI-LYTE ANA-II TEST SYSTEM
- Applicant
- Zeus Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-07
- Decision date
- 2004-10-08
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- LKJ
- 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
No recalls on record reference this clearance.
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| FLUORO-CEP (R) PROGESTERONE (P900025) | Zeus Scientific, Inc. | 1990-09-26 |