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510(k) K972257

N-ASSAY TIA ANTITHROMBIN III TEST KIT by Crestat Diagnostics, Inc. — Product Code DDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1997
Date Received
June 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Antiserum, Control, Antithrombin Iii
Device Class
Class II
Regulation Number
864.7060
Review Panel
HE
Submission Type

Other clearances by Crestat Diagnostics, Inc.

  • K980883 — N-ASSAY GLU-UL (September 3, 1998)
  • K981276 — N-ASSAY L D-BIL (May 1, 1998)
  • 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)
  • 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)

Other clearances for product code DDQ

  • K935307 — DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA (November 22, 1994)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)
  • K780012 — ANTITHROMBIN III RIA (January 20, 1978)