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510(k) K810782

TRYPAN BLUE (0.5% IN NORMAL SALINE) by Dutchland Laboratories, Inc. — Product Code LGY

K810782 is an FDA 510(k) premarket notification submitted by Dutchland Laboratories, Inc. for the device "TRYPAN BLUE (0.5% IN NORMAL SALINE)". The FDA issued a decision of Substantially Equivalent on May 13, 1981. The device falls under product code LGY (Trypan Blue), a Class I device regulated under 21 CFR 864.1850. Dutchland Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1981
Date Received
March 23, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trypan Blue
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Dutchland Laboratories, Inc.

  • K821912 — MCCOY'S POWDER MEDIUM 5A SUSPENSION (July 27, 1982)
  • K821913 — ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM (July 27, 1982)
  • K821919 — POWDERED RPMI-1634 MEDIUM (July 27, 1982)
  • K821915 — BME AUTOCLAVABLE MEDIUM (July 27, 1982)
  • K821917 — WAYMOUTH'S POWDER MEDIUM (July 27, 1982)
  • K821918 — POWDERED RPMI-1603 MEDIUM (July 27, 1982)
  • K821916 — IMPROVED MEM-RICHTER'S POWDER MODIF. (July 27, 1982)
  • K821914 — COON'S F-12 POWDER MEDIUM (July 27, 1982)
  • K821911 — S-MEM-JOKLIK'S POWDER (July 27, 1982)
  • K820927 — HBS POWDER (April 21, 1982)

FDA data resources