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510(k) K812369

GUINEA PIG COMPLEMENT VIRUS ANTIBODY by Dutchland Laboratories, Inc. — Product Code KTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1981
Date Received
August 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Complement
Device Class
Class I
Regulation Number
866.4100
Review Panel
IM
Submission Type

Other clearances by Dutchland Laboratories, Inc.

  • K821911 — S-MEM-JOKLIK'S POWDER (July 27, 1982)
  • K821915 — BME AUTOCLAVABLE MEDIUM (July 27, 1982)
  • K821914 — COON'S F-12 POWDER MEDIUM (July 27, 1982)
  • K821912 — MCCOY'S POWDER MEDIUM 5A SUSPENSION (July 27, 1982)
  • K821918 — POWDERED RPMI-1603 MEDIUM (July 27, 1982)
  • K821913 — ISCOVE'S MODIFIED DULBECCO POWDER MEDIUM (July 27, 1982)
  • K821916 — IMPROVED MEM-RICHTER'S POWDER MODIF. (July 27, 1982)
  • K821917 — WAYMOUTH'S POWDER MEDIUM (July 27, 1982)
  • K821919 — POWDERED RPMI-1634 MEDIUM (July 27, 1982)
  • K820919 — EARLE'S-199 POWDERED MEDIUM (April 21, 1982)

Other clearances for product code KTQ

  • K890417 — SPQ(TM) ANTIBODY REAGENT SET II FOR C3 (February 17, 1989)
  • K812522 — RABBIT COMPLEMENT (September 23, 1981)
  • K812370 — GUINEA PIG COMPLEMENT REGULAR (September 8, 1981)
  • K791117 — RABBIT COMPLEMENT (August 3, 1979)
  • K790380 — LOW-TOX-H RABBIT COMPLEMENT (March 21, 1979)