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510(k) K854176

POLYCHROME IV STAIN by Devetec, Inc. — Product Code LED

K854176 is an FDA 510(k) premarket notification submitted by Devetec, Inc. for the device "POLYCHROME IV STAIN". The FDA issued a decision of Substantially Equivalent on October 31, 1985. The device falls under product code LED (Stains, Chemical Solution), a Class I device regulated under 21 CFR 864.1850. Devetec, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1985
Date Received
October 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Chemical Solution
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Devetec, Inc.

  • K894045 — MODIFIED POLYCHROME IV STAIN (July 25, 1989)
  • K873594 — TIF FECAL TEST (September 29, 1987)
  • K870988 — PRICE'S ACID-FAST STAIN (March 30, 1987)

Other clearances for product code LED

  • K051409 — SLIVASURE (August 8, 2005)
  • K023046 — SST SALIVA SUPPORTING TABLETS (December 2, 2002)
  • K860795 — SPOTTEST CALCOFLUOR WHITE REAGENT (March 12, 1986)
  • K860319 — MEGACOLOR (February 20, 1986)
  • K860320 — GRANULOCOLOR (February 20, 1986)
  • K860317 — NEUTROCOLOR (February 20, 1986)
  • K860321 — LYSOCOLOR (February 20, 1986)
  • K860316 — PANOPTIKON (February 20, 1986)
  • K851481 — SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR (April 29, 1985)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)

FDA data resources