CALBIOCHEM-BEHRING RIA-COUNT
FDA 510(k) clearance K792460 · decided 1980-02-13
Clearance details
- K-number
- K792460
- Device name
- CALBIOCHEM-BEHRING RIA-COUNT
- Applicant
- Calbiochem-Behring Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-03
- Decision date
- 1980-02-13
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- CDD
- Device class
- 2
- Regulation number
- 862.1810
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.