KODATROL I AND II CONTROL AND DILUENT SET— 510(k) K904768

Clearance details

Applicant

Eastman Kodak Company

Product code

Code JJY

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

1990-10-22

Decision date

1990-11-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rochester, NY, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904768.