SALICYLATE ASSAY— 510(k) K961131
Substantially EquivalentDiagnostic Reagents, Inc.
FDA 510(k) clearance K961131 for SALICYLATE ASSAY, Substantially Equivalent on 1996-04-29. Applicant: Diagnostic Reagents, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Reagents, Inc.
- Product code
- Code DKJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3830
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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More clearances from Diagnostic Reagents, Inc.
view allRecalls naming K961131
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 K961131.
Data sourced from openFDA. This site is unofficial and independent of the FDA.