DAKO ITA SYSTEM— 510(k) K861059
Substantially EquivalentDako Corp.
FDA 510(k) clearance K861059 for DAKO ITA SYSTEM, Substantially Equivalent on 1986-08-25. Applicant: Dako Corp.. Device class: 2.
Clearance details
- Applicant
- Dako Corp.
- Product code
- Code DEW
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Barbara, CA, US
Recent devices under product code DEW
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- K991402 — DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1
- K991454 — MOUSE IGG1 NEGATIVE CONTROLS
- K980635 — DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
Data sourced from openFDA. This site is unofficial and independent of the FDA.