ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505— 510(k) K980173

Clearance details

Applicant

Beckman Instruments, Inc.

Product code

Code JHI

Device class

Class 2

Regulation

21 CFR 862.1155

Advisory panel

Clinical Chemistry

Date received

1998-01-20

Decision date

1998-03-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chaska, MN, US

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Malfunction

1,055

Total

1,055

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 →