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510(k) K884011

SNAP N' STAIN IRON STAIN by Scientific Device Laboratory, Inc. — Product Code GGH

K884011 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "SNAP N' STAIN IRON STAIN". The FDA issued a decision of Substantially Equivalent on October 6, 1988. The device falls under product code GGH (Iron Stains), 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
October 6, 1988
Date Received
September 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iron Stains
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
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)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)
  • K881598 — SDL TRICHROME STAIN (May 4, 1988)
  • K840506 — HAEMOPHILUS INFLUENZAE TYPE B (April 4, 1984)

FDA data resources