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510(k) K964257

IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT by Beckman Instruments, Inc. — Product Code LKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1997
Date Received
October 25, 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

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  • K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (May 1, 1998)
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  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (February 20, 1998)
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Other clearances for product code LKL

  • K993441 — K-ASSAY ALPHA-1 AG (November 24, 1999)
  • K964299 — N-ASSAY TIA MULTI V-NL (July 14, 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)