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510(k) K842918

SCOTTS TAP WATER SUBSTITUTE by E K Ind., Inc. — Product Code JCC

K842918 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "SCOTTS TAP WATER SUBSTITUTE". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code JCC (Ph Buffer), 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 11, 1984
Date Received
July 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Buffer
Device Class
Class I
Regulation Number
864.4010
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)
  • K842935 — ACETIC ACID, 5% 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)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)
  • K842933 — CARBOL-FUCHSIN, ZIEHL-NEEDSEN (September 11, 1984)

Other clearances for product code JCC

  • K842914 — WRIGHT STAIN BUFFER (September 7, 1984)
  • K841423 — SCOTTS TAP WATER SUBSTITUTE 7 (May 22, 1984)
  • K811791 — PHOSPHATE BUFFERED SALINE (1X) (August 25, 1981)
  • K811251 — CITRATE BUFFER (May 21, 1981)
  • K792574 — MOPSO BUFFER (January 21, 1980)
  • K770508 — SMAC SYSTEM (May 9, 1977)

FDA data resources