VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)— 510(k) K964721

Clearance details

Applicant

Johnson & Johnson Clinical Diagnostics, Inc.

Product code

Code KLI

Device class

Class 2

Regulation

21 CFR 862.1700

Advisory panel

Clinical Chemistry

Date received

1996-11-25

Decision date

1996-12-18

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 K964721.