WH ACCU TEST PREGNANCY TEST— 510(k) K012284

Clearance details

Applicant

W.H.P.M., Inc.

Product code

Product code JHI

Device class

Class 2

Regulation

21 CFR 862.1155

Advisory panel

Clinical Chemistry

Date received

2001-07-20

Decision date

2001-08-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beverly, MA, 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 →