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510(k) K810766

HANKS' BALANCED SALT SOLUTION W/O CA-MG by Dutchland Laboratories, Inc. — Product Code KIP

K810766 is an FDA 510(k) premarket notification submitted by Dutchland Laboratories, Inc. for the device "HANKS' BALANCED SALT SOLUTION W/O CA-MG". The FDA issued a decision of Substantially Equivalent on May 8, 1981. 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
May 8, 1981
Date Received
March 23, 1981
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)
  • K820928 — EBS POWDER (April 21, 1982)

Other clearances for product code KIP

  • 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)
  • K870482 — (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 (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)
  • 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