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510(k) K993251

IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 by Diagnostic Products Corp. — Product Code LIG

K993251 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6". The FDA issued a decision of Substantially Equivalent on November 17, 1999. The device falls under product code LIG (Radioassay, Intrinsic Factor Blocking Antibody), a Class II device regulated under 21 CFR 862.1810. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1999
Date Received
September 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Intrinsic Factor Blocking Antibody
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

Other clearances by Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code LIG

  • K240800 — Access Intrinsic Factor Ab (May 3, 2024)
  • K071346 — IMMULISA INTRINSIC FACTOR ANTIBODY ELISA (September 24, 2007)
  • K061841 — QUANTA LITE INTRINSIC FACTOR ELISA (December 22, 2006)
  • K033603 — INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MOD (December 19, 2003)
  • K984108 — ABBOTT ARCHITECT B12 (February 3, 1999)
  • K903218 — IMX B12 (August 23, 1990)
  • K811927 — 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY (April 1, 1982)

FDA data resources