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510(k) K872701

RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL by Sita, Inc. — Product Code LKT

K872701 is an FDA 510(k) premarket notification submitted by Sita, Inc. for the device "RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL". The FDA issued a decision of Substantially Equivalent on September 18, 1987. The device falls under product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa), a Class I device regulated under 21 CFR 866.3480. Sita, Inc. has at least 8 other 510(k) clearances on record.

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
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

Other clearances by Sita, Inc.

  • K872700 — YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN (October 15, 1987)
  • K872693 — INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872699 — MUMPS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872698 — ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872696 — PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872697 — PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872695 — PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872694 — YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)

Other clearances for product code LKT

  • K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT (December 23, 2008)
  • K983336 — PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 (March 18, 1999)
  • K943317 — PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) (December 19, 1994)
  • K942173 — RSV ANTIGEN TEST (June 30, 1994)
  • K912842 — RSV-MAB TEST (December 9, 1991)
  • K912838 — BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO (September 27, 1991)
  • K912371 — BIOMERIEUX RSV DIRECT IF KIT (September 23, 1991)
  • K894623 — RESPIRATORY SYNCYTIAL VIRUS (October 16, 1989)
  • K884192 — RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION (November 22, 1988)
  • K882687 — ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST (August 30, 1988)

FDA data resources