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510(k) K010031

NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM by Wescor, Inc. — Product Code KTB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2001
Date Received
January 3, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Specific Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

Other clearances by Wescor, Inc.

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  • 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)
  • K834208 — COLLOID OSMOMETER 4400 (March 23, 1984)
  • K840472 — SYS MACRODUCT SWEAT COLLECTION SYS 3600 (March 19, 1984)
  • K833295 — WESCOR 7100 AEROSPRAY SLIDE STAINER (October 31, 1983)

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  • K031115 — RH-900 (July 10, 2003)
  • K001522 — TRANSQ3 (October 18, 2000)
  • K001410 — PHORESOR MODEL PM2000 (August 1, 2000)
  • K992874 — Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM (November 18, 1999)
  • K974855 — PHORESOR II, MODEL PM900 (March 27, 1998)
  • K954126 — TRANSQ ELECTRODE PHORESOR II (January 19, 1996)
  • K895775 — CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM (April 23, 1990)