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510(k) K820928

EBS POWDER by Dutchland Laboratories, Inc. — Product Code KIP

K820928 is an FDA 510(k) premarket notification submitted by Dutchland Laboratories, Inc. for the device "EBS POWDER". The FDA issued a decision of Substantially Equivalent on April 21, 1982. The device falls under product code KIP (Formulations, Balanced Salt Solutions), a Class I device regulated under 21 CFR 864.2875. Dutchland Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1982
Date Received
April 1, 1982
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 Dutchland Laboratories, Inc.

  • K821918 — POWDERED RPMI-1603 MEDIUM (July 27, 1982)
  • K821913 — ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM (July 27, 1982)
  • K821915 — BME AUTOCLAVABLE MEDIUM (July 27, 1982)
  • K821912 — MCCOY'S POWDER MEDIUM 5A SUSPENSION (July 27, 1982)
  • K821914 — COON'S F-12 POWDER MEDIUM (July 27, 1982)
  • K821917 — WAYMOUTH'S POWDER MEDIUM (July 27, 1982)
  • K821916 — IMPROVED MEM-RICHTER'S POWDER MODIF. (July 27, 1982)
  • K821911 — S-MEM-JOKLIK'S POWDER (July 27, 1982)
  • K821919 — POWDERED RPMI-1634 MEDIUM (July 27, 1982)
  • K820926 — E-BME POWDERED MEDIUM (April 21, 1982)

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)
  • K842725 — SALINE, 0.85%W/PRESERVATIVE (August 3, 1984)
  • K842723 — SALINE, 1.3% W/O PRESERVATIVE (August 3, 1984)
  • K842724 — SALINE 0.85% W/O PRESERVATIVE (August 3, 1984)

FDA data resources