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510(k) K843997

AO-10 AUTOMATED OSMOMETER by bioMerieux, Inc. — Product Code JJM

K843997 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "AO-10 AUTOMATED OSMOMETER". The FDA issued a decision of Substantially Equivalent on October 31, 1984. The device falls under product code JJM (Osmometer For Clinical Use), a Class I device regulated under 21 CFR 862.2730. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
October 11, 1984
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

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Other clearances for product code JJM

  • K965036 — THE ADVANCED OSMOMETER (3900) (February 20, 1997)
  • 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)
  • 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