Home / 510(k) Clearances / K881598

510(k) K881598

SDL TRICHROME STAIN by Scientific Device Laboratory, Inc. — Product Code JTS

K881598 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "SDL TRICHROME STAIN". The FDA issued a decision of Substantially Equivalent on May 4, 1988. The device falls under product code JTS (Stains, Microbiologic), a Class I device regulated under 21 CFR 864.1850. Scientific Device Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1988
Date Received
April 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Microbiologic
Device Class
Class I
Regulation Number
864.1850
Review Panel
MI
Submission Type

Other clearances by Scientific Device Laboratory, Inc.

  • K935316 — PARASAFE(R) FIXATIVE (February 17, 1994)
  • K924893 — MICROSPORIDIUM CONTROL SLIDE (January 15, 1993)
  • K911059 — TURBIDOMETRIC STANDARD (June 10, 1991)
  • K895848 — PRESSURE STEAM STERILIZERS (December 11, 1989)
  • K890718 — GRAM STAIN CONTROL SLIDE (March 16, 1989)
  • K890670 — CRYPTOSPORIDIUM CONTROL SLIDE (March 16, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K884011 — SNAP N' STAIN IRON STAIN (October 6, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)
  • K840506 — HAEMOPHILUS INFLUENZAE TYPE B (April 4, 1984)

Other clearances for product code JTS

  • K960095 — BACTIDROP CALCOFLUOR WHITE (March 19, 1996)
  • K960090 — CALCOFLUOR WHITE STAIN KIT (March 19, 1996)
  • K920975 — BACTIDROP CALCOFLUOR WHITE (June 9, 1992)
  • K920976 — BACTIDROP INDIA INK (June 9, 1992)
  • K920970 — BACTIDROP KOH (10%) (June 9, 1992)
  • K893530 — IRISTAIN FORMULA 2, PARTS 1 AND 2 (June 13, 1989)
  • K890861 — ATS DOBELL & O'CONNOR'S IODINE (March 23, 1989)
  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)

FDA data resources