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510(k) K843665

PARAINFLUENZA 1 by Institute Virion , Ltd. — Product Code GQS

K843665 is an FDA 510(k) premarket notification submitted by Institute Virion , Ltd. for the device "PARAINFLUENZA 1". The FDA issued a decision of Substantially Equivalent on September 26, 1985. The device falls under product code GQS (Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4), a Class I device regulated under 21 CFR 866.3400. Institute Virion , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1985
Date Received
September 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Institute Virion , Ltd.

  • K862814 — COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI (September 30, 1986)
  • K843662 — MEASLES VIRUS RUBEOLA (September 26, 1985)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K843673 — RESPIRATORY SYNCYTIAL VIRUS (September 26, 1985)
  • K843657 — CYTOMEGALOVIRUS (September 26, 1985)
  • K843660 — IN FLUENZA B VIRUS (September 26, 1985)
  • K843658 — H. SIMPLEX VIRUS (September 26, 1985)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)
  • K843649 — ADENOVIRUS (September 26, 1985)
  • K843659 — INFLUENZA A2 VIRUS (September 26, 1985)

Other clearances for product code GQS

  • K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (December 23, 2009)
  • K943557 — IMAGEN (January 9, 1995)
  • K905385 — P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (March 21, 1991)
  • K884194 — PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT (November 22, 1988)
  • K884193 — PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT (November 22, 1988)
  • K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (June 26, 1987)
  • K871234 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (June 26, 1987)
  • K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (June 26, 1987)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K802935 — PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR (December 31, 1980)

FDA data resources