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510(k) K944847

KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM by Starplex Scientific, Inc. — Product Code JSL

K944847 is an FDA 510(k) premarket notification submitted by Starplex Scientific, Inc. for the device "KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 16, 1995. The device falls under product code JSL (Culture Media, Anaerobic Transport), a Class I device regulated under 21 CFR 866.2390. Starplex Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1995
Date Received
September 30, 1994
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 by Starplex Scientific, Inc.

  • K032246 — MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (August 13, 2003)
  • K022388 — STARTOX DRUG OF ABUSE SCREENING TEST (4) (February 27, 2003)
  • K021006 — STARTOX DRUG OF ABUSE SCREENING TEST (June 10, 2002)
  • K962843 — MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (September 18, 1996)
  • K960997 — STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM (April 3, 1996)
  • K924364 — VACUPLUS TUBES WITH GREY STOPPERS (March 1, 1993)
  • K924362 — VACUPLUS TUBES WITH LAVANDER STOPPERS (March 1, 1993)
  • K924361 — VACUPLUS TUBES WITH GREEN STOPPERS (March 1, 1993)
  • K924363 — VACUPLUS(R) STAR-SEP(TM) (February 8, 1993)
  • K924365 — VACUPLUS TUBES WITH BRICK RED STOPPERS (December 28, 1992)

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)
  • K925450 — BIONOR TRANSPORTMEDIUM (June 25, 1993)
  • 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