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510(k) K991277

MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 by Diagnostic Products Corp. — Product Code DDR

K991277 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5". The FDA issued a decision of Substantially Equivalent on April 27, 1999. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1999
Date Received
April 14, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Myoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5680
Review Panel
IM
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 DDR

  • K231832 — Access Myoglobin (September 18, 2023)
  • K123785 — DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET (June 7, 2013)
  • K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR (October 3, 2012)
  • K083260 — ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (October 16, 2009)
  • K080481 — ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CA (February 20, 2009)
  • K061683 — TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (July 21, 2006)
  • K042924 — ARCHITECT STAT MYO IMMUNOASSAY (January 24, 2005)
  • K042982 — QUANTEX MYOGLOBIN (December 22, 2004)
  • K033300 — VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERI (November 5, 2003)
  • K021229 — MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973 (June 28, 2002)

FDA data resources