AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)— 510(k) K912024

Clearance details

Applicant

Wako Chemicals USA, Inc.

Product code

Code JJE

Device class

Class 1

Regulation

21 CFR 862.2160

Advisory panel

Clinical Chemistry

Date received

1991-05-03

Decision date

1991-07-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Richmond, VA, US

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Death

6

Injury

441

Malfunction

25,011

Other

1

Total

25,459

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →