DISCOVER(R)
FDA 510(k) clearance K882232 · decided 1988-10-25
Clearance details
- K-number
- K882232
- Device name
- DISCOVER(R)
- Applicant
- Carter Products
- Decision
- Substantially Equivalent
- Date received
- 1988-05-27
- Decision date
- 1988-10-25
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cranbury, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.