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510(k) K860793

CAMCO STAIN PAK by Cambridge Chemical Products, Inc. — Product Code IAF

K860793 is an FDA 510(k) premarket notification submitted by Cambridge Chemical Products, Inc. for the device "CAMCO STAIN PAK". The FDA issued a decision of Substantially Equivalent on March 18, 1986. The device falls under product code IAF (Wright'S Stain), a Class I device regulated under 21 CFR 864.1850. Cambridge Chemical Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1986
Date Received
March 4, 1986
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 Cambridge Chemical Products, Inc.

  • K830223 — FECAL OCCULT SLIDE TEST KIT (March 7, 1983)
  • K781347 — CAMCO QUIK STAIN II (August 21, 1978)
  • K770153 — CAMCO R PAK-GUAIAC (February 8, 1977)

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)
  • 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)
  • K831605 — HEMATOLOGY PAK (June 30, 1983)

FDA data resources