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510(k) K834208

COLLOID OSMOMETER 4400 by Wescor, Inc. — Product Code JJM

K834208 is an FDA 510(k) premarket notification submitted by Wescor, Inc. for the device "COLLOID OSMOMETER 4400". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code JJM (Osmometer For Clinical Use), a Class I device regulated under 21 CFR 862.2730. Wescor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
December 5, 1983
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 Wescor, Inc.

  • K121823 — CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLOR (March 27, 2013)
  • K010031 — NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM (March 20, 2001)
  • K863395 — WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER (May 24, 1988)
  • K881592 — WESCOR MODEL 7300 AEROSPRAY GRAM STAINER (May 13, 1988)
  • K881512 — WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY (April 18, 1988)
  • K880544 — WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY (April 1, 1988)
  • K853973 — WESCOR MODEL 3700 WEBSTER SWEAT INDUCER (October 16, 1985)
  • K834214 — WESCOR 5500 VAPOR PRESSURE OSMOMETER (March 30, 1984)
  • K840472 — SYS MACRODUCT SWEAT COLLECTION SYS 3600 (March 19, 1984)
  • K830429 — WEIL PERFUSOMETER #100 (October 31, 1983)

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)
  • 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)
  • K832783 — MICRO-SAMPLE OSMOMETER 3M0 (November 28, 1983)
  • K811179 — OSMOMETER MODEL OM-6010 (May 15, 1981)

FDA data resources