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510(k) K833260

STAIN PACK FOR AEROSPRAY SLIDE STAINER by Wescor, Inc. — Product Code IAF

K833260 is an FDA 510(k) premarket notification submitted by Wescor, Inc. for the device "STAIN PACK FOR AEROSPRAY SLIDE STAINER". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code IAF (Wright'S Stain), a Class I device regulated under 21 CFR 864.1850. Wescor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
September 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wright'S Stain
Device Class
Class I
Regulation Number
864.1850
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 IAF

  • K890674 — ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET (February 24, 1989)
  • K890673 — WRIGHT-GLEMSA STAIN (February 24, 1989)
  • K854236 — HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (October 10, 1986)
  • K860793 — CAMCO STAIN PAK (March 18, 1986)
  • K853241 — HEMATOLOGY STAIN PACK (August 19, 1985)
  • K852138 — WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S (June 13, 1985)
  • K842744 — WRIGHT STAIN (August 12, 1984)
  • K842745 — WRIGHT-GIEMSA QUICK STAIN (August 10, 1984)
  • K833678 — HEMATOLOGY WRIGHT'S STAIN PACK (November 25, 1983)
  • K831605 — HEMATOLOGY PAK (June 30, 1983)

FDA data resources