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510(k) K823363

COUNT-10 STAIN by V-Tech, Inc. — Product Code LEE

K823363 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "COUNT-10 STAIN". The FDA issued a decision of Substantially Equivalent on December 15, 1982. The device falls under product code LEE (Stains, Dye Solution), a Class I device regulated under 21 CFR 864.1850. V-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1982
Date Received
November 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by V-Tech, Inc.

  • K914303 — TARGET(TM)-HOG (October 11, 1991)
  • K910892 — TARGET(TM) CANNABINOIDS-V TEST (April 3, 1991)
  • K910893 — TARGET(TM) CANNABINOIDS-R TEST (April 3, 1991)
  • K910739 — TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) (March 21, 1991)
  • K910738 — TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) (March 19, 1991)
  • K910123 — TARGET COCAINE METABOLITE-V (March 19, 1991)
  • K910122 — TARGET COCAINE METABOLITE-R (March 19, 1991)
  • K903937 — TARGET(TM) HOG ONE STEP (October 22, 1990)
  • K890978 — TARGET OPIATES-R (November 17, 1989)
  • K890979 — TARGET OPIATES-V (October 4, 1989)

FDA data resources