Home / 510(k) Clearances / K842722

510(k) K842722

BUFFERED SALINE by E K Ind., Inc. — Product Code JCE

K842722 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "BUFFERED SALINE". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code JCE (Solution, Isotonic), 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 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Isotonic
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)
  • 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)
  • K842934 — DECOLORIZING FLUIC, ACID-ALCOHOL 3% (September 12, 1984)
  • K842933 — CARBOL-FUCHSIN, ZIEHL-NEEDSEN (September 11, 1984)
  • K842927 — LIGHT GREEN SF 1% (September 11, 1984)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)
  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)

Other clearances for product code JCE

  • K831200 — IMMUNOHEMATOLOGICAL SALINE #97139 (May 9, 1983)
  • K801506 — CERTIFIED BLOOD BANK SALINE (July 28, 1980)
  • K792101 — COUITER/CMS ISOTONIC BLOOD BANK SALINE (November 20, 1979)
  • K761183 — LYSING AGENT AF (January 17, 1977)
  • K761174 — PHYSIOLOGIC SALINE (0.85%) (January 10, 1977)
  • K761170 — BARBITAL SALINE BUFFER (January 10, 1977)

FDA data resources