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510(k) K933575

VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT by Symex Corp. — Product Code GQP

K933575 is an FDA 510(k) premarket notification submitted by Symex Corp. for the device "VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT". The FDA issued a decision of Substantially Equivalent on November 28, 1994. The device falls under product code GQP (Antisera, Neutralization, Parainfluenza Virus 1-4), a Class I device regulated under 21 CFR 866.3400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1994
Date Received
July 23, 1993
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 for product code GQP

  • K981226 — IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VI (September 28, 1998)

FDA data resources