EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
FDA 510(k) clearance K871638 · decided 1987-05-12
Clearance details
- K-number
- K871638
- Device name
- EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
- Applicant
- Em Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-04-27
- Decision date
- 1987-05-12
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JIX
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Gibbstown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.