CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002
FDA 510(k) clearance K980514 · decided 1998-03-04
Clearance details
- K-number
- K980514
- Device name
- CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002
- Applicant
- Medical Analysis Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-02-10
- Decision date
- 1998-03-04
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Camarillo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.