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510(k) K801212

WRIGHTS RAPID STAIN by Mcb Manufacturing Chemists, Inc. — Product Code IAF

K801212 is an FDA 510(k) premarket notification submitted by Mcb Manufacturing Chemists, Inc. for the device "WRIGHTS RAPID STAIN". The FDA issued a decision of Substantially Equivalent on May 30, 1980. The device falls under product code IAF (Wright'S Stain), a Class I device regulated under 21 CFR 864.1850. Mcb Manufacturing Chemists, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1980
Date Received
May 20, 1980
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 Mcb Manufacturing Chemists, Inc.

  • K800847 — ENTELLAN (May 8, 1980)
  • K792026 — WRIGHTS RAPID STAIN (November 13, 1979)
  • K791929 — WRIGHTS RAPID STAIN (October 11, 1979)
  • K782066 — EXETRELUT (January 3, 1979)

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)
  • K833260 — STAIN PACK FOR AEROSPRAY SLIDE STAINER (October 28, 1983)

FDA data resources