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510(k) K951364

MICROSOMAL EIA TEST KIT by Immunoprobe, Inc. — Product Code JNL

K951364 is an FDA 510(k) premarket notification submitted by Immunoprobe, Inc. for the device "MICROSOMAL EIA TEST KIT". The FDA issued a decision of Substantially Equivalent on November 20, 1995. The device falls under product code JNL (Immunochemical, Thyroglobulin Autoantibody), a Class II device regulated under 21 CFR 866.5870. Immunoprobe, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1995
Date Received
March 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunochemical, Thyroglobulin Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

Other clearances by Immunoprobe, Inc.

  • K972406 — ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM (December 22, 1997)
  • K971393 — MYCOPLASMA IGG ELISA TEST SYSTEM (July 14, 1997)
  • K961765 — MPO ELISA TEST SYSTEM (August 19, 1996)
  • K961764 — PR-3 ELISA TEST SYSTEM (August 19, 1996)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K952523 — CARDIOLIPIN IGG EIA TEST KIT (February 9, 1996)
  • K952522 — CARDIOLIPIN IGA EIA TEST SYSTEM (February 9, 1996)
  • K952521 — CARDIOLIPIN IGM EIA TEST SYSTEM (February 9, 1996)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)
  • K951363 — CARDIOLIPIN IGG,M,A EIA TEST SYSTEM (October 13, 1995)

Other clearances for product code JNL

  • K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII) (December 4, 2025)
  • K240996 — Access Thyroglobulin Antibody II (July 3, 2024)
  • K112933 — ACCESS THYROGLOBULIN ANITBODY (December 27, 2011)
  • K072661 — IMMUNOCAP THYRLOBULIN IMMUNOCAP (November 20, 2007)
  • K062516 — ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALI (October 5, 2006)
  • K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (July 3, 1997)
  • K962341 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) (November 25, 1996)
  • K962451 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) (November 25, 1996)
  • K954256 — ANTI-TPO (November 27, 1995)
  • K951362 — THYROGLOBULIN EIA TEST KIT (November 20, 1995)

FDA data resources