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510(k) K191085

Maverick RNP Assay and Maverick Diagnostic System by Genalyte, Inc. — Product Code LKO

K191085 is an FDA 510(k) premarket notification submitted by Genalyte, Inc. for the device "Maverick RNP Assay and Maverick Diagnostic System". The FDA issued a decision of Substantially Equivalent on October 25, 2019. The device falls under product code LKO (Anti-Rnp Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Genalyte, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2019
Date Received
April 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Rnp Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Genalyte, Inc.

  • K234091 — Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 (July 22, 2024)

Other clearances for product code LKO

  • K140224 — EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) (December 9, 2014)
  • K123261 — EUROIMMUN ANTI-NRNP/SM ELISA (IGG) (June 12, 2013)
  • K083117 — ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODEL (May 28, 2009)
  • K071210 — MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 (December 19, 2007)
  • K022017 — RHIGENE MESACUP-2 TEST RNP, MODEL M7741 (August 14, 2002)
  • K000752 — RHIGENE MESACUP2 TEST- RNP (May 9, 2000)
  • K993589 — VARELISA RNP ANTIBODIES (November 26, 1999)
  • K990624 — AUTOSTAT II ANTI-SM/RNP ELISA (April 28, 1999)
  • K984476 — LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 (December 22, 1998)
  • K983465 — THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LIN (November 18, 1998)

FDA data resources