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510(k) K880544

WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY by Wescor, Inc. — Product Code GJL

K880544 is an FDA 510(k) premarket notification submitted by Wescor, Inc. for the device "WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY". The FDA issued a decision of Substantially Equivalent on April 1, 1988. The device falls under product code GJL (Romanowsky Stains), 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
April 1, 1988
Date Received
February 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Romanowsky Stains
Device Class
Class I
Regulation Number
864.1850
Review Panel
HE
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)
  • 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)
  • K830429 — WEIL PERFUSOMETER #100 (October 31, 1983)

FDA data resources