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510(k) K812365

PARA 1 SENDAI HEMAGGLUTININ by Dutchland Laboratories, Inc. — Product Code GQR

K812365 is an FDA 510(k) premarket notification submitted by Dutchland Laboratories, Inc. for the device "PARA 1 SENDAI HEMAGGLUTININ". The FDA issued a decision of Substantially Equivalent on September 9, 1981. The device falls under product code GQR (Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4), a Class I device regulated under 21 CFR 866.3400. Dutchland Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1981
Date Received
August 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4
Device Class
Class I
Regulation Number
866.3400
Review Panel
MI
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)

FDA data resources