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510(k) K842924

ORANGE G, 1% by E K Ind., Inc. — Product Code HZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1984
Date Received
July 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orange G
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by E K Ind., Inc.

  • K842931 — DRABKIN REAGENT (September 21, 1984)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842934 — DECOLORIZING FLUIC, ACID-ALCOHOL 3% (September 12, 1984)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)
  • K842928 — JENNER BLOOD STAIN (September 11, 1984)
  • K842739 — PAP STAIN, EA-36 (September 11, 1984)
  • K842925 — MUCI-CARMINE STAIN, MAYER'S FORMULA (September 11, 1984)
  • K842927 — LIGHT GREEN SF 1% (September 11, 1984)

Other clearances for product code HZH

  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K811825 — ORANGE G-6 (July 10, 1981)
  • K800323 — VOLU-SOL ORANGE G-6 STAIN (February 22, 1980)