Home / 510(k) Clearances / K963640

510(k) K963640

OLYMPUS ACID PHOSPHATASE REAGENT by Olympus America, Inc. — Product Code CKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1997
Date Received
September 12, 1996
Clearance Type
Traditional
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

Other clearances by Olympus America, Inc.

  • K111788 — ENDOEYE HD II (January 13, 2012)
  • K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (March 18, 2009)
  • K073487 — OLYMPUS IGM REAGENT (February 11, 2008)
  • K073490 — OLYMPUS IGG REAGENT (February 11, 2008)
  • K073489 — OLYMPUS IGA REAGENT (February 11, 2008)
  • K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (April 6, 2007)
  • K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM (March 23, 2007)
  • K061499 — OSFERION (January 26, 2007)
  • K062581 — OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM (November 29, 2006)
  • K061575 — OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 (October 5, 2006)

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)
  • K981743 — OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (June 9, 1998)
  • K974695 — COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES W (May 21, 1998)
  • 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)