SANGUI BIOTECH, INC. CALCITONIN ELISA KIT— 510(k) K982491
Substantially EquivalentSangui Biotech, Inc.
FDA 510(k) clearance K982491 for SANGUI BIOTECH, INC. CALCITONIN ELISA KIT, Substantially Equivalent on 1998-09-03. Applicant: Sangui Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Sangui Biotech, Inc.
- Product code
- Code JKR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1140
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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More clearances from Sangui Biotech, Inc.
view allRecalls naming K982491
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982491.
Data sourced from openFDA. This site is unofficial and independent of the FDA.