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510(k) K933575

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

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)