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510(k) K841139

COLUMBIA AGAR W/COLISTIN, NALADIXIC by Anaerobe Systems — Product Code JSJ

K841139 is an FDA 510(k) premarket notification submitted by Anaerobe Systems for the device "COLUMBIA AGAR W/COLISTIN, NALADIXIC". The FDA issued a decision of Substantially Equivalent on March 26, 1984. The device falls under product code JSJ (Culture Media, Selective And Non-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
March 26, 1984
Date Received
March 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Anaerobe Systems

  • K844382 — VANCOMYCIN 5MCG DIFFERENTIAL DISK (January 4, 1985)
  • K844383 — KANAMYCIN 1000 MCG DIFFERENTIAL DISK (January 4, 1985)
  • K844380 — BILE DIFFERENTIAL DISK (January 4, 1985)
  • K844381 — COLISTIN 10 MCG. 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)
  • K841138 — MUELLER HINTON AGAR W/BLOOD & COFACTOR (April 4, 1984)
  • K841222 — BACTEROIDES BILE ESCULIN GAR (April 4, 1984)
  • K841221 — BRAIN HEART INFUSION BROTH (April 4, 1984)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)

FDA data resources