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510(k) K841142

LEVINE EOSIN METHYLENE BLUE AGAR by Anaerobe Systems — Product Code JSI

K841142 is an FDA 510(k) premarket notification submitted by Anaerobe Systems for the device "LEVINE EOSIN METHYLENE BLUE AGAR". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Anaerobe Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1984
Date Received
March 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

Other clearances by Anaerobe Systems

  • K844380 — BILE DIFFERENTIAL DISK (January 4, 1985)
  • 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)
  • K841303 — CAMPYLOBACTER THIOGLYCOLLATE MED (April 17, 1984)
  • K841218 — CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR (April 5, 1984)
  • K841222 — BACTEROIDES BILE ESCULIN GAR (April 4, 1984)
  • K841138 — MUELLER HINTON AGAR W/BLOOD & COFACTOR (April 4, 1984)
  • K841221 — BRAIN HEART INFUSION BROTH (April 4, 1984)
  • K841220 — ANAEROBIC TRANSPORT MEDIUM (April 4, 1984)

Other clearances for product code JSI

  • K070691 — BBL CHROMAGAR 0157 (November 20, 2007)
  • K974428 — DIPSTREAK (July 30, 1998)
  • K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM (June 9, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K882182 — SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 (June 6, 1988)
  • K881572 — XL AGAR BASE (April 18, 1988)
  • K881576 — SELENITE BROTH (April 18, 1988)
  • K881575 — SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)
  • K881555 — TINSDALE AGAR BASE (April 18, 1988)
  • K881577 — MODIFIED SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)

FDA data resources