TRACE ELEMENTS SERUM TOXICOLOGY CONTROL— 510(k) K883147

Clearance details

Applicant

Utak Laboratories, Inc.

Product code

Code JJY

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

1988-07-26

Decision date

1988-10-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Canyon Country, CA, US

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• Z-2407-2020 — Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.Class III·Terminated·Utak Laboratories Inc·20200320

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K883147.