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510(k) K925450

BIONOR TRANSPORTMEDIUM by Skoug Research Corp. — Product Code JSL

K925450 is an FDA 510(k) premarket notification submitted by Skoug Research Corp. for the device "BIONOR TRANSPORTMEDIUM". The FDA issued a decision of Substantially Equivalent on June 25, 1993. The device falls under product code JSL (Culture Media, Anaerobic Transport), a Class I device regulated under 21 CFR 866.2390.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1993
Date Received
October 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Anaerobic Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

Other clearances for product code JSL

  • K972449 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL (August 20, 1997)
  • K972448 — COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL (August 20, 1997)
  • K944847 — KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM (February 16, 1995)
  • K841220 — ANAEROBIC TRANSPORT MEDIUM (April 4, 1984)
  • K834357 — ANA TRANS TUBE & SWABS STERILE PACK (January 31, 1984)
  • K770840 — PRE-REDUCED ANAEROBIC MEDIA (June 8, 1977)
  • K770650 — PRE-DUCED CULTURE MEDIA (April 15, 1977)

FDA data resources