CALCIUM, CATALOGUE NUMBER140-20
FDA 510(k) clearance K895873 · decided 1989-12-12
Clearance details
- K-number
- K895873
- Device name
- CALCIUM, CATALOGUE NUMBER140-20
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1989-10-04
- Decision date
- 1989-12-12
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- CJY
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Oxford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.