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510(k) K842733

GRAM IODINE by E K Ind., Inc. — Product Code HYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1984
Date Received
July 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iodine, Grams
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 HYI

  • K871286 — GRAM IODINE (April 8, 1987)
  • K821977 — GRAMSTAIN SET (July 22, 1982)
  • K811722 — PARA-PAK (July 15, 1981)
  • K791711 — IMPROVED GRAM STAIN REAGENTS (October 17, 1979)
  • K781584 — GRAM STAIN KIT (October 10, 1978)