Home / 510(k) Clearances / K853611

510(k) K853611

APL XYLOSE LYSINE DEOXYCHOLATE AGAR by Apl Medical Supplies — Product Code JSI

K853611 is an FDA 510(k) premarket notification submitted by Apl Medical Supplies for the device "APL XYLOSE LYSINE DEOXYCHOLATE AGAR". The FDA issued a decision of Substantially Equivalent on September 12, 1985. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Apl Medical Supplies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1985
Date Received
August 29, 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 Apl Medical Supplies

  • K853619 — APL TRIPLE SUGAR IRON AGAR (September 16, 1985)
  • K853610 — APL MOTILITY INDOLE ORNITHINE AGAR (September 16, 1985)
  • K853618 — APL SIM MEDIUM (September 16, 1985)
  • K853617 — APL SIMMONS CITRATE AGAR (September 16, 1985)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K853613 — APL GN BROTH (September 6, 1985)
  • K853616 — APL CHLAMYDOSPORE AGAR (September 6, 1985)
  • K853612 — APL DNASE TEST AGAR (September 6, 1985)
  • K853615 — APL BILE ESCULIN/AZIDE AGAR (September 6, 1985)
  • K853614 — APL FLUID THIOGLYCOLLATE MEDIUM (September 6, 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)
  • 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