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510(k) K861387

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) by Eastman Kodak Company — Product Code JHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1986
Date Received
April 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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Other clearances for product code JHS

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  • K102706 — CKMB UDR ASSAY (August 19, 2011)
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  • K062128 — THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS (August 21, 2006)
  • K990439 — CARESIDE CK (April 19, 1999)
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  • K981495 — IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) (June 10, 1998)
  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
  • K952250 — STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIME (July 17, 1995)
  • K945083 — ACCESS CK-MB REAGENTS (November 21, 1994)