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510(k) K852578

CLED AGAR by American Laboratory Supply, Inc. — Product Code JSH

K852578 is an FDA 510(k) premarket notification submitted by American Laboratory Supply, Inc. for the device "CLED AGAR". The FDA issued a decision of Substantially Equivalent on July 12, 1985. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. American Laboratory Supply, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1985
Date Received
June 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by American Laboratory Supply, Inc.

  • K844932 — MALT AGAR (February 27, 1985)
  • K844933 — BILE ESCULIN AGAR (February 27, 1985)
  • K844931 — MYCOLOGICAL AGAR W/ANTIBIOTICS (February 27, 1985)
  • K844929 — INHIBITORY MOLD AGAR (February 27, 1985)
  • K844930 — BRILLANT GREEN 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)
  • K820559 — ANAEROBE BLOOD AGAR (March 19, 1982)

Other clearances for product code JSH

  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

FDA data resources