510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993251Substantially Equivalent

Immulite 2000 Vitamin B12, Model L2kvb2, L2kvb6

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993251 is the FDA 510(k) clearance record for IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6, a class II device, cleared for Diagnostic Products Corp. on under FDA product code LIG (Radioassay, Intrinsic Factor Blocking Antibody). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show one recall naming K993251.

Clearance record

Decision date
Received
(50 days to decision)
Product code
LIG Radioassay, Intrinsic Factor Blocking Antibody
Regulation
21 CFR 862.1810
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
510(k) summary
Summary
Third party review
No

Clearances, product code LIG

Trailing 12 months

FDA records hold no clearances under product code LIG in the trailing twelve months.

FDA records show no clearances under product code LIG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260