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510(k) K842724

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

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)
  • 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 KIP

  • K870482 — (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 (March 30, 1987)
  • K870491 — KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 (March 30, 1987)
  • K870486 — EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 (March 30, 1987)
  • K870484 — HANKS' BALANCED SALTS (HBSS) NO. H1387 (March 30, 1987)
  • K860784 — DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 (March 12, 1986)
  • K844877 — HEPES BUFFER IM IN NORMAL SALINE (February 25, 1985)
  • K844878 — TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG (February 25, 1985)
  • K842723 — SALINE, 1.3% W/O PRESERVATIVE (August 3, 1984)
  • K842725 — SALINE, 0.85%W/PRESERVATIVE (August 3, 1984)
  • K820928 — EBS POWDER (April 21, 1982)