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510(k) K861379

MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT by Serono Diagnostics, Inc. — Product Code LKT

K861379 is an FDA 510(k) premarket notification submitted by Serono Diagnostics, Inc. for the device "MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT". The FDA issued a decision of Substantially Equivalent on July 16, 1986. The device falls under product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa), a Class I device regulated under 21 CFR 866.3480. Serono Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1986
Date Received
April 14, 1986
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 Serono Diagnostics, Inc.

  • K953598 — SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS (March 11, 1996)
  • K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY (July 13, 1994)
  • K883085 — T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS (September 9, 1988)
  • K882340 — LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (August 8, 1988)
  • K880388 — T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE (March 3, 1988)
  • K874866 — T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE (February 11, 1988)
  • K873431 — PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH (October 20, 1987)
  • K873186 — LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA (September 29, 1987)
  • K873400 — PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA (September 25, 1987)
  • K872862 — PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS (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