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510(k) K812027

KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) by Eastman Kodak Company — Product Code CIW

K812027 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)". The FDA issued a decision of Substantially Equivalent on August 3, 1981. The device falls under product code CIW (Starch-Dye Bound Polymer, Amylase), a Class II device regulated under 21 CFR 862.1070. Eastman Kodak Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1981
Date Received
July 20, 1981
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 Eastman Kodak Company

  • K060550 — KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 (March 31, 2006)
  • K060137 — KODAK ECLIPSE IMAGE PROCESSING SOFTWARE (March 16, 2006)
  • K060079 — KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM (February 8, 2006)
  • K060055 — KODAK PACS (February 7, 2006)
  • K053347 — KODAK CARESTREAM PACS (January 4, 2006)
  • K051483 — KODAK DIRECTVIEW DR SYSTEM DETECTOR (June 21, 2005)
  • K051258 — KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 (June 1, 2005)
  • K042159 — KODAK COLOR MEDICAL IMAGER 1000 (September 24, 2004)
  • K042158 — KODAK MEDICAL IMAGER 300 (September 24, 2004)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)

Other clearances for product code CIW

  • K931559 — DMA AMYLASE PROCEDURE (October 28, 1993)
  • K924339 — OLYMPUS AMYLASE REAGENT (October 19, 1992)
  • K884382 — AMYLASE TEST (AMYL) ITEM NUMBER: 65653 (January 11, 1989)
  • K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT (March 5, 1985)
  • K810584 — PHADEBAS ISOAMYLASE TEST (May 13, 1981)
  • K810669 — PANTRAK E.K. (March 31, 1981)
  • K782032 — UNITEST AMYLASE (March 2, 1979)

FDA data resources