FDA · official record K830187Substantially Equivalent

FOCUS FLUID

Name: FOCUS FLUID — FDA K830187
Creator: Hematology Marketing Assoc.
Keywords: FOCUS FLUID, FOCUS FLUID, K830187, EIF, FDA

United StatesEIFHematology Marketing Assoc.

Verified

Official record identity

FDA application number: K830187
Decision date: March 01, 1983
Published decision: Substantially Equivalent

Classification

Product code: EIF

Published parties

Applicant: Hematology Marketing Assoc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1983-01-19
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4565

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.