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510(k) K930486

QUANTA LITE(TM) THYROID T ELISA by Inova Diagnostics, Inc. — Product Code DDC

K930486 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE(TM) THYROID T ELISA". The FDA issued a decision of Substantially Equivalent on March 15, 1993. The device falls under product code DDC (Thyroglobulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5870. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1993
Date Received
January 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thyroglobulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

Other clearances by Inova Diagnostics, Inc.

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  • K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (December 17, 2024)
  • K213403 — Aptiva CTD Essential Reagent (September 29, 2023)
  • K200230 — Aptiva Celiac Disease IgG Reagent (August 26, 2021)
  • K193604 — Aptiva Celiac Disease IgA Reagent (June 16, 2021)
  • K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae Kit (December 11, 2020)
  • K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (April 17, 2019)
  • K180971 — QUANTA Flash Calprotectin and Fecal Extraction Device (October 16, 2018)
  • K180975 — QUANTA Flash HMGCR Reagents (June 25, 2018)
  • K170993 — QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANT (December 22, 2017)

Other clearances for product code DDC

  • K023592 — SERAQUEST ANTI-THYROGLOBULIN (January 6, 2003)
  • K012208 — ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, (September 7, 2001)
  • K000363 — MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (February 18, 2000)
  • K991610 — ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. (June 25, 1999)
  • K991179 — ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM (June 17, 1999)
  • K971835 — ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (July 3, 1997)
  • K953066 — SERODIA ATG (August 14, 1995)
  • K943625 — AUTOSTAT II ANTI-THYROGLOBULIN (December 22, 1994)
  • K936010 — THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY (July 18, 1994)
  • K865020 — SERA-TEK THYROGLOBULIN ANTIBODY TEST (February 2, 1987)

FDA data resources