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510(k) K841586

CHOCOLATE AGAR by Microline Scientific — Product Code KZI

K841586 is an FDA 510(k) premarket notification submitted by Microline Scientific for the device "CHOCOLATE AGAR". The FDA issued a decision of Substantially Equivalent on May 31, 1984. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. Microline Scientific has 13 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1984
Date Received
Apr 17, 1984
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
510(k) Exempt

Other clearances by Microline Scientific

  • K841842 — DIFFERENTIAL CULTURE MED. MACCONKEY AGAR (May 31, 1984)
  • K841845 — SELECTIVE CULTURE MED. COLUMBIA CNA (May 31, 1984)
  • K841843 — DIFFERENTIAL CULTURE MED. LEVINE EMB (May 31, 1984)
  • K841844 — DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR (May 31, 1984)
  • K841841 — DIFFERENTIAL CULTURE MED. MANNITOL SALT (May 25, 1984)
  • K841839 — SELECTIVE CULTURE MED. SELECTIVE STREP (May 25, 1984)
  • K841840 — SELECTIVE CULTURE MED. PHENYLETHYL ALCO (May 25, 1984)
  • K841838 — ENRICHED CULTURE MED. TRYPTIC SOY AGAR (May 21, 1984)
  • K841837 — ENRICHED CULTURE MED. FLUID THIOGLYC0 (May 21, 1984)
  • K841835 — MULTIPURPOSE CULTURE MEDIUM (May 14, 1984)

Other clearances for product code KZI

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

FDA data resources

Source: FDA 510(k) database entry for K841586. Report a data issue: hello@regdatalab.com.