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510(k) K842734

SAFRANIN STAIN by E K Ind., Inc. — Product Code HZS

K842734 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "SAFRANIN STAIN". The FDA issued a decision of Substantially Equivalent on August 17, 1984. The device falls under product code HZS (Safranin), a Class I device regulated under 21 CFR 864.1850. E K Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1984
Date Received
July 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Safranin
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)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)
  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842933 — CARBOL-FUCHSIN, ZIEHL-NEEDSEN (September 11, 1984)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)
  • K842927 — LIGHT GREEN SF 1% (September 11, 1984)

FDA data resources