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510(k) K980540

SERAQUEST ANTI-SM by Quest Intl., Inc. — Product Code LKP

K980540 is an FDA 510(k) premarket notification submitted by Quest Intl., Inc. for the device "SERAQUEST ANTI-SM". The FDA issued a decision of Substantially Equivalent on June 15, 1998. The device falls under product code LKP (Anti-Sm Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Quest Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1998
Date Received
February 12, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Quest Intl., Inc.

  • K091260 — SERAQUEST EBV EA-D IGG TEST (June 8, 2009)
  • K033915 — MODIFICATION TO SERAQUEST EB VCA IGG (January 16, 2004)
  • K033780 — MODIFICATION TO SERAQUEST VCA IGM (January 15, 2004)
  • K023593 — SERAQUEST ANTI-THYROID PEROXIDASE (TPO) (February 6, 2003)
  • K023592 — SERAQUEST ANTI-THYROGLOBULIN (January 6, 2003)
  • K003069 — ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM (November 27, 2000)
  • K991975 — SERAQUEST EB NA IGG (November 2, 1999)
  • K990410 — SERAQUEST EB VCA IGG (October 28, 1999)
  • K990977 — SERAQUEST EB VAC IGM (October 6, 1999)
  • K982485 — SERAQUEST CMV IGM (January 13, 1999)

Other clearances for product code LKP

  • K202067 — EliA SmDP-S (July 14, 2021)
  • K183007 — EliA SmDP Immunoassay (December 24, 2018)
  • K132631 — EIA SMDP IMMUNOASSAY (August 29, 2014)
  • K123593 — QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP (April 17, 2013)
  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
  • K042629 — VARELISA SM ANTIBODIES, MODEL 18296 (December 8, 2004)
  • K024219 — LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (January 15, 2003)
  • K013263 — FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (July 29, 2002)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)

FDA data resources