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510(k) K842934

DECOLORIZING FLUIC, ACID-ALCOHOL 3% by E K Ind., Inc. — Product Code PPM

K842934 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "DECOLORIZING FLUIC, ACID-ALCOHOL 3%". The FDA issued a decision of Substantially Equivalent on September 12, 1984. The device falls under product code PPM (General Purpose Reagent), a Class I device regulated under 21 CFR 864.4010. E K Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1984
Date Received
July 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
General Purpose Reagent
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

Other clearances by E K Ind., Inc.

  • K842931 — DRABKIN REAGENT (September 21, 1984)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842927 — LIGHT GREEN SF 1% (September 11, 1984)
  • K842731 — FORMALIN-ACETO-ALCOHOL FIXATIVE (September 11, 1984)
  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)
  • K842933 — CARBOL-FUCHSIN, ZIEHL-NEEDSEN (September 11, 1984)

Other clearances for product code PPM

  • K871533 — TOMTEC GRAM STAINER DECOLORIZER (April 29, 1987)
  • K863550 — POTASSIUM HYDROXIDE 10% W/V (October 2, 1986)
  • K861890 — 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 (June 3, 1986)
  • K850916 — SPRAYFIX (March 25, 1985)
  • K850737 — TRANSPORT CULTURE MEDIUM (March 20, 1985)
  • K850845 — 0.85% SALINE (March 20, 1985)
  • K842863 — PRO-SOFT DEHYDRANT (August 21, 1984)
  • K842729 — DECOLORIZING FLUID (August 3, 1984)
  • K842070 — IDD DETERGENT (July 2, 1984)
  • K831620 — SODIUM HYPOCHLORITE 3% (July 28, 1983)

FDA data resources