EA-D IGM ELISA TEST SYSTEM
FDA 510(k) clearance K982350 · decided 1998-11-25
Clearance details
- K-number
- K982350
- Device name
- EA-D IGM ELISA TEST SYSTEM
- Applicant
- Columbia Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-06
- Decision date
- 1998-11-25
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- LSE
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.