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510(k) K834357

ANA TRANS TUBE & SWABS STERILE PACK by Anaerobe Systems — Product Code JSL

K834357 is an FDA 510(k) premarket notification submitted by Anaerobe Systems for the device "ANA TRANS TUBE & SWABS STERILE PACK". The FDA issued a decision of Substantially Equivalent on January 31, 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
January 31, 1984
Date Received
December 13, 1983
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

  • K844383 — KANAMYCIN 1000 MCG DIFFERENTIAL DISK (January 4, 1985)
  • K844382 — VANCOMYCIN 5MCG DIFFERENTIAL DISK (January 4, 1985)
  • K844381 — COLISTIN 10 MCG. DIFFERENTIAL DISK (January 4, 1985)
  • K844380 — BILE DIFFERENTIAL DISK (January 4, 1985)
  • K841303 — CAMPYLOBACTER THIOGLYCOLLATE MED (April 17, 1984)
  • K841142 — LEVINE EOSIN METHYLENE BLUE AGAR (April 5, 1984)
  • K841218 — CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR (April 5, 1984)
  • K841222 — BACTEROIDES BILE ESCULIN GAR (April 4, 1984)
  • K841221 — BRAIN HEART INFUSION BROTH (April 4, 1984)
  • K841220 — ANAEROBIC TRANSPORT MEDIUM (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)
  • K841220 — ANAEROBIC TRANSPORT MEDIUM (April 4, 1984)
  • K770840 — PRE-REDUCED ANAEROBIC MEDIA (June 8, 1977)
  • K770650 — PRE-DUCED CULTURE MEDIA (April 15, 1977)

FDA data resources