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510(k) K964299

N-ASSAY TIA MULTI V-NL by Crestat Diagnostics, Inc. — Product Code LKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1997
Date Received
October 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5420
Review Panel
IM
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)
  • K980902 — N-ASSAY L AST/GOT (March 26, 1998)
  • K980900 — N-ASSAY CPK-L (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)

Other clearances for product code LKL

  • K993441 — K-ASSAY ALPHA-1 AG (November 24, 1999)
  • K964257 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT (March 24, 1997)
  • K922417 — AL-ACID GLYCOPROTEIN RID KIT (August 20, 1992)
  • K904175 — RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT (November 13, 1990)
  • K884217 — TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN (November 4, 1988)
  • K873868 — ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) (October 20, 1987)
  • K862087 — SANTEST 1AP (December 3, 1986)
  • K861336 — IAP PLATE TEST (April 25, 1986)
  • K841734 — TAGO FIFFU-GEN, OROSOMUCOID (June 1, 1984)
  • K831960 — TEST FOR HUMAN ALPHA ONE ACID GLYCO- (July 19, 1983)