Folic Acid

• • Terminated Z-0569-2014 FDA Class II ·initiated 6 Nov 2013

  potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. This may lead to a failed adjustment before the labeled expiration date is reached.

510(k) Number

K943705 ↗

FDA Product Code

CGN

Device Class

Class II

Regulation

21 CFR Part 862.1295

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Coat-A-Count T4 Ria Kit

  Class II

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• Immulite(R) Tbg

  Class I

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• Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests)

  Class II

  FDA 510(k) K012301 Active Cleared 19 Sep 2001

• Coat-A-Count Direct Androstenedione

  Class I

  FDA 510(k) K954755 Active Cleared 29 Nov 1995

See all devices from Diagnostic Products Corp. →