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510(k) K093415

D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT by Diagnostic Hybrids, Inc. — Product Code GQS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2009
Date Received
November 2, 2009
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

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  • K090073 — D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (March 6, 2009)
  • K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (December 23, 2008)

Other clearances for product code GQS

  • K943557 — IMAGEN (January 9, 1995)
  • K905385 — P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (March 21, 1991)
  • K884193 — PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT (November 22, 1988)
  • K884194 — PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT (November 22, 1988)
  • K871234 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (June 26, 1987)
  • K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (June 26, 1987)
  • K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (June 26, 1987)
  • K843665 — PARAINFLUENZA 1 (September 26, 1985)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K802935 — PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR (December 31, 1980)