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510(k) K851603

XYLOSE LYSINE DESOXYCHOLATE AGAR by Preferred Micro-Media — Product Code JSI

K851603 is an FDA 510(k) premarket notification submitted by Preferred Micro-Media for the device "XYLOSE LYSINE DESOXYCHOLATE AGAR". The FDA issued a decision of Substantially Equivalent on May 8, 1985. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Preferred Micro-Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1985
Date Received
April 16, 1985
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 Preferred Micro-Media

  • K851594 — SF BROTH (May 14, 1985)
  • K851592 — SABOURAUD DEXTROSE AGAR (May 13, 1985)
  • K851597 — TRIPLE SUGAR IRON AGAR (May 13, 1985)
  • K851595 — SIMMONS CITRATE AGAR (May 13, 1985)
  • K851591 — PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD (May 13, 1985)
  • K851593 — SELECTIVE STREPTOCOCCUS AGAR (May 13, 1985)
  • K851596 — SIM MEDIUM (May 13, 1985)
  • K851598 — THIOGLYCOLLATE WITHOUT INDICATOR (May 10, 1985)
  • K851576 — BIGGY AGAR NICKERSONS MEDIUM (May 9, 1985)
  • K851578 — BILE ESCULIN AGAR (May 8, 1985)

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)
  • K881577 — MODIFIED SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)
  • K881572 — XL AGAR BASE (April 18, 1988)
  • K881555 — TINSDALE AGAR BASE (April 18, 1988)
  • K881576 — SELENITE BROTH (April 18, 1988)
  • K881575 — SELECTIVE STREPTOCOCCUS AGAR (April 18, 1988)

FDA data resources