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510(k) K831605

HEMATOLOGY PAK by Mercedes Scientific Co., Inc. — Product Code IAF

K831605 is an FDA 510(k) premarket notification submitted by Mercedes Scientific Co., Inc. for the device "HEMATOLOGY PAK". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code IAF (Wright'S Stain), a Class I device regulated under 21 CFR 864.1850. Mercedes Scientific Co., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
May 18, 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 Mercedes Scientific Co., Inc.

  • K830127 — QUIK-DIP BLOOD STAIN (February 15, 1983)

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