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510(k) K840506

HAEMOPHILUS INFLUENZAE TYPE B by Scientific Device Laboratory, Inc. — Product Code LSC

K840506 is an FDA 510(k) premarket notification submitted by Scientific Device Laboratory, Inc. for the device "HAEMOPHILUS INFLUENZAE TYPE B". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code LSC (Neisseria Controls), a Class I device regulated under 21 CFR 866.2660. Scientific Device Laboratory, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
February 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neisseria Controls
Device Class
Class I
Regulation Number
866.2660
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)
  • K881598 — SDL TRICHROME STAIN (May 4, 1988)

Other clearances for product code LSC

  • K840509 — NEISSERIA MENINGITIDIS GR. B (March 23, 1984)
  • K840507 — NEISSERIA MENINGITIDIS GR. Y (March 23, 1984)
  • K840514 — NEISSERIA MENINGITIDIS CONTROL (March 23, 1984)
  • K840504 — SDL NEISSERIA MENINGITIDES GR. 2 (March 23, 1984)
  • K840505 — SDL NEISSERIA MENNINGITIDIS GR. X (March 23, 1984)
  • K840510 — NEISSERIA MENINGITIDIS GR. A (March 23, 1984)

FDA data resources