Immulite 2000 Vitamin B12, Model L2KVB2, L2KVB6

• • Terminated Z-0537-05 FDA Unclassified (pre-2012) ·initiated 24 Jan 2005 ·on shared 510(k) K993251

  A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K993251 ↗

FDA Product Code

LIG

Device Class

Class II

Regulation

21 CFR Part 862.1810

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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