Home / 510(k) Clearances / K844381

510(k) K844381

COLISTIN 10 MCG. DIFFERENTIAL DISK by Anaerobe Systems — Product Code JTO

K844381 is an FDA 510(k) premarket notification submitted by Anaerobe Systems for the device "COLISTIN 10 MCG. DIFFERENTIAL DISK". The FDA issued a decision of Substantially Equivalent on January 4, 1985. The device falls under product code JTO (Discs, Strips And Reagents, Microorganism Differentiation), a Class I device regulated under 21 CFR 866.2660. Anaerobe Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1985
Date Received
November 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Anaerobe Systems

  • K844382 — VANCOMYCIN 5MCG DIFFERENTIAL DISK (January 4, 1985)
  • K844380 — BILE 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)
  • K841142 — LEVINE EOSIN METHYLENE BLUE 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 JTO

  • K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT (September 1, 2005)
  • K970832 — PYR SWAB (April 24, 1997)
  • K970834 — GRAM SWAB (April 17, 1997)
  • K970833 — INDOLE SWAB (April 2, 1997)
  • K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN (February 6, 1997)
  • K962966 — IDS RAPID CB PLUS SYSTEM (October 8, 1996)
  • K961191 — COLISCREEN (June 17, 1996)
  • K960996 — M. CAT BUTYRATE DISK (April 18, 1996)
  • K955826 — GIBSON ID-M. CAT. (February 29, 1996)
  • K954783 — DRYSLIDE CARTARRHALIS (February 6, 1996)

FDA data resources