510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930777Substantially Equivalent

Thyroglobulin Autoantibody Immunoassay Kit

Nichols Institute, San Juan Capistrano CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930777 is the FDA 510(k) clearance record for THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT, a class II device, cleared for Nichols Institute on under FDA product code JNL (Immunochemical, Thyroglobulin Autoantibody). FDA records list 15 510(k) clearances for Nichols Institute, from to . As of , FDA records show no recalls naming K930777.

Clearance record

Decision date
Received
(51 days to decision)
Product code
JNL Immunochemical, Thyroglobulin Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Nichols Institute 33608 Ortega Hwy., San Juan Capistrano CA
510(k) summary
Statement
Third party review
No

Clearances, product code JNL

Trailing 12 months
1 clearance under product code JNL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JNL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260