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510(k) K811791

PHOSPHATE BUFFERED SALINE (1X) by Dutchland Laboratories, Inc. — Product Code JCC

K811791 is an FDA 510(k) premarket notification submitted by Dutchland Laboratories, Inc. for the device "PHOSPHATE BUFFERED SALINE (1X)". The FDA issued a decision of Substantially Equivalent on August 25, 1981. The device falls under product code JCC (Ph Buffer), a Class I device regulated under 21 CFR 864.4010. Dutchland Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1981
Date Received
June 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Buffer
Device Class
Class I
Regulation Number
864.4010
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 JCC

  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842914 — WRIGHT STAIN BUFFER (September 7, 1984)
  • K841423 — SCOTTS TAP WATER SUBSTITUTE 7 (May 22, 1984)
  • K811251 — CITRATE BUFFER (May 21, 1981)
  • K792574 — MOPSO BUFFER (January 21, 1980)
  • K770508 — SMAC SYSTEM (May 9, 1977)

FDA data resources