EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT— 510(k) K060385
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K060385 for EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT, Substantially Equivalent on 2006-04-06. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code MLM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1678
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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Recalls naming K060385
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 K060385.
Data sourced from openFDA. This site is unofficial and independent of the FDA.