SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE— 510(k) K884184
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K884184 for SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE, Substantially Equivalent on 1989-03-28. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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