ACCESS VITAMIN B12 ASSAY (MODIFICATION)— 510(k) K955436

Clearance details

Applicant

Bio-Rad Laboratories, Inc.

Product code

Code CDD

Device class

Class 2

Regulation

21 CFR 862.1810

Advisory panel

Clinical Chemistry

Date received

1995-10-02

Decision date

1996-01-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chaska, MN, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955436.