CALCIUM ASSAY KIT, NUMBER 120-19
FDA 510(k) clearance K874496 · decided 1988-02-11
Clearance details
- K-number
- K874496
- Device name
- CALCIUM ASSAY KIT, NUMBER 120-19
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1987-11-02
- Decision date
- 1988-02-11
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- CIC
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Charlottestown,Pei,Canada, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.