SIGMA REAGENT SYSTEM NO. 885
FDA 510(k) clearance K822733 · decided 1982-12-03
Clearance details
- K-number
- K822733
- Device name
- SIGMA REAGENT SYSTEM NO. 885
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-08
- Decision date
- 1982-12-03
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- JBE
- Device class
- 2
- Regulation number
- 864.7100
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.