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510(k) K943557

IMAGEN by Dako Diagnostics , Ltd. — Product Code GQS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1995
Date Received
July 22, 1994
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 Dako Diagnostics , Ltd.

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  • K973954 — IMAGEN RESPIRATORY SCREEN (December 22, 1997)
  • K962037 — IMAGEN RESPIRATORY SCREEN (December 26, 1996)
  • K940564 — IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION (January 11, 1996)
  • K932384 — IDEIA(TM) ROTAVIRUS (December 27, 1993)

Other clearances for product code GQS

  • K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (December 23, 2009)
  • 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)
  • K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (June 26, 1987)
  • K871234 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (June 26, 1987)
  • K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (June 26, 1987)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K843665 — PARAINFLUENZA 1 (September 26, 1985)
  • K802935 — PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR (December 31, 1980)