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510(k) K841220

ANAEROBIC TRANSPORT MEDIUM by Anaerobe Systems — Product Code JSL

K841220 is an FDA 510(k) premarket notification submitted by Anaerobe Systems for the device "ANAEROBIC TRANSPORT MEDIUM". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code JSL (Culture Media, Anaerobic Transport), a Class I device regulated under 21 CFR 866.2390. Anaerobe Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
March 22, 1984
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 Anaerobe Systems

  • K844381 — COLISTIN 10 MCG. DIFFERENTIAL DISK (January 4, 1985)
  • K844382 — VANCOMYCIN 5MCG DIFFERENTIAL DISK (January 4, 1985)
  • K844383 — KANAMYCIN 1000 MCG DIFFERENTIAL DISK (January 4, 1985)
  • K844380 — BILE DIFFERENTIAL DISK (January 4, 1985)
  • K841303 — CAMPYLOBACTER THIOGLYCOLLATE MED (April 17, 1984)
  • K841218 — CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR (April 5, 1984)
  • K841142 — LEVINE EOSIN METHYLENE BLUE AGAR (April 5, 1984)
  • K841221 — BRAIN HEART INFUSION BROTH (April 4, 1984)
  • K841222 — BACTEROIDES BILE ESCULIN GAR (April 4, 1984)
  • K841138 — MUELLER HINTON AGAR W/BLOOD & COFACTOR (April 4, 1984)

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