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510(k) K820563

THIOGLYCOLLATE ENRICHED by American Laboratory Supply, Inc. — Product Code KZI

K820563 is an FDA 510(k) premarket notification submitted by American Laboratory Supply, Inc. for the device "THIOGLYCOLLATE ENRICHED". The FDA issued a decision of Substantially Equivalent on March 16, 1982. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. 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, Enriched
Device Class
Class I
Regulation Number
866.2330
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 KZI

  • K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (October 25, 1988)
  • K881995 — DIAMOND'S MEDIUM MODIFIED (June 2, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880131 — LOWENSTEIN-JENSEN, GRUFT (March 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)
  • K880109 — CYSTINE TRYPTIC MEDIUM BASE (March 30, 1988)
  • K880138 — WALLENSTEIN MEDIUM SLANT (March 30, 1988)
  • K880127 — POTATO DEXTROSE AGAR (March 7, 1988)
  • K874179 — BIOTIS (TM) SABHI (DOUBLE POUR) (January 28, 1988)
  • K874177 — BIOTIS (TM) BCYE (December 4, 1987)

FDA data resources