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510(k) K980883

N-ASSAY GLU-UL by Crestat Diagnostics, Inc. — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1998
Date Received
March 9, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Crestat Diagnostics, Inc.

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  • K981289 — N-ASSAY L T-BIL (April 27, 1998)
  • K980900 — N-ASSAY CPK-L (March 26, 1998)
  • K980902 — N-ASSAY L AST/GOT (March 26, 1998)
  • K972257 — N-ASSAY TIA ANTITHROMBIN III TEST KIT (October 20, 1997)
  • K971985 — N-ASSAY TIA PLASMINOGEN TEST KIT (October 20, 1997)
  • K964296 — N-ASSAY TIA APO B TEST KIT (August 1, 1997)
  • K964294 — N-ASSAY TIA APO A1/B MULTI CALIBRATOR (August 1, 1997)
  • K964292 — N-ASSAY TIA APO A1 TEST KIT (August 1, 1997)
  • K964298 — N-ASSAY TIA MULTI V-NL (July 14, 1997)

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