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510(k) K833295

WESCOR 7100 AEROSPRAY SLIDE STAINER by Wescor, Inc. — Product Code KPA

K833295 is an FDA 510(k) premarket notification submitted by Wescor, Inc. for the device "WESCOR 7100 AEROSPRAY SLIDE STAINER". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code KPA (Slide Stainer, Automated), a Class I device regulated under 21 CFR 864.3800. Wescor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1983
Date Received
September 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Slide Stainer, Automated
Device Class
Class I
Regulation Number
864.3800
Review Panel
PA
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)
  • K834208 — COLLOID OSMOMETER 4400 (March 23, 1984)
  • K840472 — SYS MACRODUCT SWEAT COLLECTION SYS 3600 (March 19, 1984)

Other clearances for product code KPA

  • K933996 — PROFIBLOT (January 28, 1994)
  • K884258 — VERSABLOT (December 14, 1988)
  • K881592 — WESCOR MODEL 7300 AEROSPRAY GRAM STAINER (May 13, 1988)
  • K880745 — LX-100 SLIDE STAINER (April 27, 1988)
  • K874887 — WESBLOT PROCESSOR (March 24, 1988)
  • K874897 — SAKURA DRS-60 AUTOMATIC SLIDE STAINER (January 5, 1988)
  • K872916 — HISTOMATIC SLIDE STAINER, CODE-ON VERSION (September 14, 1987)
  • K853210 — MST-1050-II X-RAY UNIT (October 10, 1985)
  • K850157 — CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS (February 27, 1985)
  • K850333 — PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS (February 27, 1985)

FDA data resources