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510(k) K852472

ABBOTT RSV EIA by Abbott Laboratories — Product Code LKT

K852472 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT RSV EIA". The FDA issued a decision of Substantially Equivalent on September 17, 1985. The device falls under product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa), a Class I device regulated under 21 CFR 866.3480. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1985
Date Received
June 11, 1985
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

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  • K222850 — HAVAb IgG II (August 10, 2023)
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  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)

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