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510(k) K981743

OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER by Olympus America, Inc. — Product Code CKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1998
Date Received
May 18, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Naphthyl Phosphate
Device Class
Class II
Regulation Number
862.1020
Review Panel
CH
Submission Type

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Other clearances for product code CKB

  • K053612 — DRI-STAT ACID PHOSPHATASE REAGENT (April 26, 2006)
  • K023840 — ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (January 7, 2003)
  • K991010 — ACP (May 19, 1999)
  • K974695 — COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES W (May 21, 1998)
  • K963640 — OLYMPUS ACID PHOSPHATASE REAGENT (February 18, 1997)
  • K943366 — IL TEST ACID PHOSPHATASE (January 29, 1996)
  • K902543 — ACID PHOSPHOTASE REAGENT TEST AND KIT (September 7, 1990)
  • K902495 — ACID PHOSPHATASE REAGENT SET (July 16, 1990)
  • K892393 — ACID PHOSPHATASE REAGENT (July 20, 1989)
  • K884747 — TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) (January 30, 1989)