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510(k) K093415

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

K093415 is an FDA 510(k) premarket notification submitted by Diagnostic Hybrids, Inc. for the device "D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT". The FDA issued a decision of Substantially Equivalent on December 23, 2009. 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. Diagnostic Hybrids, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Diagnostic Hybrids, Inc.

  • DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (May 13, 2014)
  • K092229 — THYRETAIN TM TSI REPORTER BIOASSAY (May 18, 2010)
  • K093233 — D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT (December 4, 2009)
  • K092882 — D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (October 21, 2009)
  • K091171 — D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT (September 11, 2009)
  • K092300 — MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (August 28, 2009)
  • K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM (August 28, 2009)
  • K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (May 21, 2009)
  • K090073 — D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (March 6, 2009)
  • K081746 — D3 DUET DFA INFLUENZA A/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)
  • 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)
  • K843665 — PARAINFLUENZA 1 (September 26, 1985)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K802935 — PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR (December 31, 1980)

FDA data resources