WAKO HDL-C/LDL-C CALIBRATOR— 510(k) K001005

Clearance details

Applicant

Wako Chemicals USA, Inc.

Product code

Code JIS

Device class

Class 2

Regulation

21 CFR 862.1150

Advisory panel

Clinical Chemistry

Date received

2000-03-29

Decision date

2000-06-01

Decision

Substantially Equivalent

Clearance type

Special

Location

Richmond, VA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001005.