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510(k) K981226

IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 by Dako Diagnostics , Ltd. — Product Code GQP

K981226 is an FDA 510(k) premarket notification submitted by Dako Diagnostics , Ltd. for the device "IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3". The FDA issued a decision of Substantially Equivalent on September 28, 1998. The device falls under product code GQP (Antisera, Neutralization, Parainfluenza Virus 1-4), a Class I device regulated under 21 CFR 866.3400. Dako Diagnostics , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1998
Date Received
March 24, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Neutralization, Parainfluenza Virus 1-4
Device Class
Class I
Regulation Number
866.3400
Review Panel
MI
Submission Type

Other clearances by Dako Diagnostics , Ltd.

  • K973954 — IMAGEN RESPIRATORY SCREEN (December 22, 1997)
  • K962037 — IMAGEN RESPIRATORY SCREEN (December 26, 1996)
  • K940564 — IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION (January 11, 1996)
  • K943557 — IMAGEN (January 9, 1995)
  • K932384 — IDEIA(TM) ROTAVIRUS (December 27, 1993)

Other clearances for product code GQP

  • K933575 — VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT (November 28, 1994)

FDA data resources