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510(k) K812192

LACTO-PHENOL ANILINE BLUE MOUNTING FLUID by American Scientific Products — Product Code LED

K812192 is an FDA 510(k) premarket notification submitted by American Scientific Products for the device "LACTO-PHENOL ANILINE BLUE MOUNTING FLUID". The FDA issued a decision of Substantially Equivalent on August 31, 1981. The device falls under product code LED (Stains, Chemical Solution), a Class I device regulated under 21 CFR 864.1850. American Scientific Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1981
Date Received
August 3, 1981
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 American Scientific Products

  • K864824 — INFECTIOUS TISSUE KIT (December 24, 1986)
  • K844042 — BLOOD DILUTION VIAL (October 23, 1984)
  • K831634 — GLUCOSE REAGENT B6360-11 (July 19, 1983)
  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A (July 7, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K831571 — ROTOR (June 30, 1983)

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)
  • K854176 — POLYCHROME IV STAIN (October 31, 1985)
  • K851481 — SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR (April 29, 1985)

FDA data resources