510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961678Substantially Equivalent

Human Growth Hormone Immunoassay Kit

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

K961678 is the FDA 510(k) clearance record for HUMAN GROWTH HORMONE IMMUNOASSAY KIT, a class I device, cleared for Nichols Institute Diagnostics on under FDA product code CFL (Radioimmunoassay, Human Growth Hormone). FDA records list 68 510(k) clearances for Nichols Institute Diagnostics, from to . As of , FDA records show no recalls naming K961678.

Clearance record

Decision date
Received
(68 days to decision)
Product code
CFL Radioimmunoassay, Human Growth Hormone
Regulation
21 CFR 862.1370
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Nichols Institute Diagnostics 33608 Ortega Hwy., San Juan Capistrano CA
510(k) summary
Statement
Third party review
No

Clearances, product code CFL

Trailing 12 months

FDA records hold no clearances under product code CFL in the trailing twelve months.

FDA records show no clearances under product code CFL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260