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510(k) K022118

IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) by Diagnostic Products Corp. — Product Code JHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2002
Date Received
July 1, 2002
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

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  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)
  • K021208 — IMMULITE 2000 MIXED ALLERGEN PANELS (May 30, 2002)

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