510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964635Substantially Equivalent

Nichols Advantage Chemiluminescence Calcitonin Kit

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

K964635 is the FDA 510(k) clearance record for NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT, a class II device, cleared for Nichols Institute Diagnostics on under FDA product code JKR (Radioimmunoassay, Calcitonin). FDA records list 68 510(k) clearances for Nichols Institute Diagnostics, from to . As of , FDA records show no recalls naming K964635.

Clearance record

Decision date
Received
(183 days to decision)
Product code
JKR Radioimmunoassay, Calcitonin
Regulation
21 CFR 862.1140
Device class
Class II
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 JKR

Trailing 12 months
1 clearance under product code JKR in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JKR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260