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510(k) K820553

BILE ESCULIN AZIDE AGAR by American Laboratory Supply, Inc. — Product Code JSI

K820553 is an FDA 510(k) premarket notification submitted by American Laboratory Supply, Inc. for the device "BILE ESCULIN AZIDE AGAR". The FDA issued a decision of Substantially Equivalent on March 16, 1982. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. American Laboratory Supply, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1982
Date Received
March 2, 1982
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 American Laboratory Supply, Inc.

  • K852578 — CLED AGAR (July 12, 1985)
  • K844932 — MALT AGAR (February 27, 1985)
  • K844929 — INHIBITORY MOLD AGAR (February 27, 1985)
  • K844931 — MYCOLOGICAL AGAR W/ANTIBIOTICS (February 27, 1985)
  • K844930 — BRILLANT GREEN AGAR (February 27, 1985)
  • K844933 — BILE ESCULIN AGAR (February 27, 1985)
  • K844934 — AZIDE AGAR W/5% SHEEP BLOOD (February 25, 1985)
  • K820550 — POTATO DEXTROSE AGAR (March 19, 1982)
  • K820562 — CAMPYLOBACTER SELECTIVE MEDIUM (March 19, 1982)
  • K820560 — PHENYLETHANOL AGAR W/5% SHEEP BLOOD (March 19, 1982)

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