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510(k) K034055

IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I by Diagnostic Products Corp. — Product Code JHX

K034055 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I". The FDA issued a decision of Substantially Equivalent on Jan 21, 2004. The device falls under product code JHX (Fluorometric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Diagnostic Products Corp. has 320 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 21, 2004
Date Received
Dec 30, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Fluorometric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type
510(k)

Other clearances by Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (Dec 5, 2006)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (Dec 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (Oct 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (Dec 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN… (Dec 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (Aug 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (Jul 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (Jun 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)
  • K021208 — IMMULITE 2000 MIXED ALLERGEN PANELS (May 30, 2002)

Other clearances for product code JHX

  • K234005 — Access CK-MB (Feb 16, 2024)
  • K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack (Jan 28, 2022)
  • K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (Sep 21, 2017)
  • K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX… (Nov 21, 2012)
  • K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II (Aug 17, 2009)
  • K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS… (Sep 8, 2005)
  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (Jul 21, 2004)
  • K033747 — RAMP CK-MB ASSAY (May 17, 2004)
  • K030012 — CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND… (Jan 17, 2003)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (Jul 22, 2002)

FDA data resources

Source: FDA 510(k) database entry for K034055. Report a data issue: hello@regdatalab.com.