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510(k) K844721

INNOFLUOR PRIMIDONE by Innotron Diagnostics — Product Code LKT

K844721 is an FDA 510(k) premarket notification submitted by Innotron Diagnostics for the device "INNOFLUOR PRIMIDONE". The FDA issued a decision of Substantially Equivalent on January 8, 1985. The device falls under product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa), a Class I device regulated under 21 CFR 866.3480. Innotron Diagnostics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1985
Date Received
December 4, 1984
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 Innotron Diagnostics

  • K850629 — INNOFLUOR THEOPHYLLINE (March 12, 1985)
  • K841866 — INNOFLOUR TOBRAMYCIN (May 31, 1984)
  • K841865 — INNOFLOUR GENTAMICIN (May 31, 1984)
  • K841707 — INNOFLUOR PHENOBARBITAL (May 23, 1984)
  • K841706 — INNOFLUOR PHENYTOIN (May 22, 1984)

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