510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965036Substantially Equivalent

The Advanced Osmometer (3900)

Advanced Instruments, LLC, Norwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965036 is the FDA 510(k) clearance record for THE ADVANCED OSMOMETER (3900), a class I device, cleared for Advanced Instruments, Inc. on under FDA product code JJM (Osmometer For Clinical Use). FDA records list 16 510(k) clearances for Advanced Instruments, Inc., from to . As of , FDA records show no recalls naming K965036.

Clearance record

Decision date
Received
(65 days to decision)
Product code
JJM Osmometer For Clinical Use
Regulation
21 CFR 862.2730
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Advanced Instruments, Inc. Two Technology Way, Norwood MA
510(k) summary
Statement
Third party review
No

Clearances, product code JJM

Trailing 12 months

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

FDA records show no clearances under product code JJM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJM, 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