CEN · Class I · 21 CFR 862.1550

FDA Product Code CEN: Dye-indicator, Ph (urinary, Non-quantitative)

Leading manufacturers include Abbott Laboratories and Helena Laboratories.

11

Total

11

Cleared

102d

Avg days

1982

Since

FDA 510(k) Cleared Dye-indicator, Ph (urinary, Non-quantitative) Devices (Product Code CEN)

11 devices

1–11 of 11

Cleared May 05, 1983

HELENA BIOSTRIP PH

Helena Laboratories

Chemistry · 37d

Cleared Oct 26, 1982

FOLATE/B12 DUO-BEAD RADIOASSAY

Abbott Laboratories

Chemistry · 91d

About Product Code CEN - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,450 total devices indexed.

Latest clearance: Aug 31, 2009

Product Code Info

Code	CEN
Device class	Class I
CFR	21 CFR 862.1550
Panel	Chemistry

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