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JJM — Osmometer For Clinical Use Class I

FDA Device Classification

FDA product code JJM covers "Osmometer For Clinical Use", a Class I medical device regulated under 21 CFR 862.2730. Submissions are reviewed by the Clinical Chemistry panel. At least 12 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
JJM
Device Class
Class I
Regulation Number
862.2730
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K965036advanced instrumentsTHE ADVANCED OSMOMETER (3900)February 20, 1997
K962056advanced instrumentsADVANCED MICRO-OSMOMETER MODEL 3300July 11, 1996
K925970advanced instrumentsMODEL 3D3 OSMOMETERJuly 9, 1993
K911092advanced instrumentsOSMOMETER MODEL 2400May 22, 1991
K873642advanced instrumentsOSMOMETER MODEL 110October 20, 1987
K843997biomerieuxAO-10 AUTOMATED OSMOMETEROctober 31, 1984
K842750kyoto diagnosticsOSMOTIC PRESSURE AUTO & STAT OM-6010August 17, 1984
K834214wescorWESCOR 5500 VAPOR PRESSURE OSMOMETERMarch 30, 1984
K834208wescorCOLLOID OSMOMETER 4400March 23, 1984
K832783advanced instrumentsMICRO-SAMPLE OSMOMETER 3M0November 28, 1983
K811179fiske med scienceOSMOMETER MODEL OM-6010May 15, 1981
K790611advanced instrumentsOSMOMETER MODEL 3W11June 15, 1979

FDA data resources