Home / 510(k) Clearances / K842725

510(k) K842725

SALINE, 0.85%W/PRESERVATIVE by E K Ind., Inc. — Product Code KIP

K842725 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "SALINE, 0.85%W/PRESERVATIVE". The FDA issued a decision of Substantially Equivalent on August 3, 1984. The device falls under product code KIP (Formulations, Balanced Salt Solutions), a Class I device regulated under 21 CFR 864.2875. E K Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1984
Date Received
July 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formulations, Balanced Salt Solutions
Device Class
Class I
Regulation Number
864.2875
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)
  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)

Other clearances for product code KIP

  • K870486 — EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 (March 30, 1987)
  • K870482 — (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 (March 30, 1987)
  • K870491 — KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 (March 30, 1987)
  • K870484 — HANKS' BALANCED SALTS (HBSS) NO. H1387 (March 30, 1987)
  • K860784 — DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 (March 12, 1986)
  • K844878 — TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG (February 25, 1985)
  • K844877 — HEPES BUFFER IM IN NORMAL SALINE (February 25, 1985)
  • K842723 — SALINE, 1.3% W/O PRESERVATIVE (August 3, 1984)
  • K842724 — SALINE 0.85% W/O PRESERVATIVE (August 3, 1984)
  • K820928 — EBS POWDER (April 21, 1982)

FDA data resources