TRYPAN BLUE (0.5% IN NORMAL SALINE)— 510(k) K810782

Name: FDA 510(k) clearance K810782
Creator: U.S. Food and Drug Administration
Published: 1981-05-13

Substantially Equivalent

Dutchland Laboratories, Inc.

FDA 510(k) clearance K810782 for TRYPAN BLUE (0.5% IN NORMAL SALINE), Substantially Equivalent on 1981-05-13. Applicant: Dutchland Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Dutchland Laboratories, Inc.
Product code: Code LGY
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1981-03-23
Decision date: 1981-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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