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510(k) K854454

TRYPTIC SOY BLOOD AGAR by R. Kent Richards, Inc. — Product Code KZI

K854454 is an FDA 510(k) premarket notification submitted by R. Kent Richards, Inc. for the device "TRYPTIC SOY BLOOD AGAR". The FDA issued a decision of Substantially Equivalent on November 18, 1985. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. R. Kent Richards, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1985
Date Received
November 5, 1985
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 R. Kent Richards, Inc.

  • K871065 — CHLAMYDIA & VIRAL TRANSPORT MEDIUM (April 14, 1987)
  • K854452 — MANNITOL SALT AGAR (November 18, 1985)
  • K854451 — MUELLER HINTON MEDIUM (November 18, 1985)
  • K854455 — CDC ANAEROBE BLOOD AGAR (November 18, 1985)
  • K854456 — CAMPYLOBACTER BLOOD AGAR (November 18, 1985)
  • K854449 — HEKTOEN ENTERIC AGAR (November 18, 1985)
  • K854457 — COLUMBIA CNA AGAR W/5% SHEEP BLOOD (November 18, 1985)
  • K854453 — P.E.Z. AGAR (PHENYLETHANOL AGAR) (November 18, 1985)
  • K854450 — BILE ESCULIN AZIDE AGAR (November 18, 1985)
  • K854275 — THAYER-MARTIN MEDIUM (MOD) (November 12, 1985)

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