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510(k) K965036

THE ADVANCED OSMOMETER (3900) by Advanced Instruments, Inc. — Product Code JJM

K965036 is an FDA 510(k) premarket notification submitted by Advanced Instruments, Inc. for the device "THE ADVANCED OSMOMETER (3900)". The FDA issued a decision of Substantially Equivalent on February 20, 1997. The device falls under product code JJM (Osmometer For Clinical Use), a Class I device regulated under 21 CFR 862.2730. Advanced Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1997
Date Received
December 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Osmometer For Clinical Use
Device Class
Class I
Regulation Number
862.2730
Review Panel
CH
Submission Type

Other clearances by Advanced Instruments, Inc.

  • K152776 — Glocyte Automated Cell Counter System (May 27, 2016)
  • K120631 — PATIENT MONITOR (May 25, 2012)
  • K112465 — VITAL SIGNS MONITOR (September 14, 2011)
  • K962056 — ADVANCED MICRO-OSMOMETER MODEL 3300 (July 11, 1996)
  • K930526 — INTERMITTENT COMPRESSION SYSTEM MODEL 5000 (November 18, 1993)
  • K925970 — MODEL 3D3 OSMOMETER (July 9, 1993)
  • K911092 — OSMOMETER MODEL 2400 (May 22, 1991)
  • K873642 — OSMOMETER MODEL 110 (October 20, 1987)
  • K863516 — ELECTRONIC METAL LOCATOR MODEL MD-1 (September 30, 1986)
  • K842784 — CEREGROTRAC (January 10, 1985)

Other clearances for product code JJM

  • K962056 — ADVANCED MICRO-OSMOMETER MODEL 3300 (July 11, 1996)
  • K925970 — MODEL 3D3 OSMOMETER (July 9, 1993)
  • K911092 — OSMOMETER MODEL 2400 (May 22, 1991)
  • K873642 — OSMOMETER MODEL 110 (October 20, 1987)
  • K843997 — AO-10 AUTOMATED OSMOMETER (October 31, 1984)
  • K842750 — OSMOTIC PRESSURE AUTO & STAT OM-6010 (August 17, 1984)
  • K834214 — WESCOR 5500 VAPOR PRESSURE OSMOMETER (March 30, 1984)
  • K834208 — COLLOID OSMOMETER 4400 (March 23, 1984)
  • K832783 — MICRO-SAMPLE OSMOMETER 3M0 (November 28, 1983)
  • K811179 — OSMOMETER MODEL OM-6010 (May 15, 1981)

FDA data resources