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510(k) K872699

MUMPS CF ANTIGEN AND CONTROL ANTIGEN by Sita, Inc. — Product Code GRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1987
Date Received
July 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Mumps Virus
Device Class
Class I
Regulation Number
866.3380
Review Panel
MI
Submission Type

Other clearances by Sita, Inc.

  • K872700 — YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN (October 15, 1987)
  • K872696 — PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872694 — YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872697 — PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872698 — ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872701 — RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL (September 18, 1987)
  • K872695 — PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872693 — INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)

Other clearances for product code GRB

  • K872733 — FIAX TEST KIT FOR MUMPS-G ANTIBODIES (October 6, 1987)