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510(k) K924339

OLYMPUS AMYLASE REAGENT by Olympus Corp. — Product Code CIW

K924339 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "OLYMPUS AMYLASE REAGENT". The FDA issued a decision of Substantially Equivalent on October 19, 1992. The device falls under product code CIW (Starch-Dye Bound Polymer, Amylase), a Class II device regulated under 21 CFR 862.1070. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1992
Date Received
August 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Starch-Dye Bound Polymer, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

Other clearances by Olympus Corp.

  • K915402 — EW-10 AND EW-20 (June 23, 1995)
  • K933200 — OLYMPUS PBD STENTS (April 5, 1995)
  • K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES (November 30, 1994)
  • K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (August 29, 1994)
  • K934835 — FLOVAL (June 21, 1994)
  • K931764 — HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES (June 8, 1994)
  • K915857 — FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (March 11, 1994)
  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
  • K934889 — OLYMPUS IMAGEMANAGER SYSTEM (January 28, 1994)
  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)

Other clearances for product code CIW

  • K931559 — DMA AMYLASE PROCEDURE (October 28, 1993)
  • K884382 — AMYLASE TEST (AMYL) ITEM NUMBER: 65653 (January 11, 1989)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K812027 — KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) (August 3, 1981)
  • K810584 — PHADEBAS ISOAMYLASE TEST (May 13, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K782032 — UNITEST AMYLASE (March 2, 1979)

FDA data resources