ALBUMIN (BCG) REAGENT— 510(k) K861467
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K861467 for ALBUMIN (BCG) REAGENT, Substantially Equivalent on 1986-05-23. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.