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510(k) K854457

COLUMBIA CNA AGAR W/5% SHEEP BLOOD by R. Kent Richards, Inc. — Product Code JSJ

K854457 is an FDA 510(k) premarket notification submitted by R. Kent Richards, Inc. for the device "COLUMBIA CNA AGAR W/5% SHEEP BLOOD". The FDA issued a decision of Substantially Equivalent on November 18, 1985. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. 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, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
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)
  • K854454 — TRYPTIC SOY BLOOD AGAR (November 18, 1985)
  • K854451 — MUELLER HINTON MEDIUM (November 18, 1985)
  • K854455 — CDC ANAEROBE BLOOD AGAR (November 18, 1985)
  • K854449 — HEKTOEN ENTERIC AGAR (November 18, 1985)
  • K854450 — BILE ESCULIN AZIDE AGAR (November 18, 1985)
  • K854456 — CAMPYLOBACTER BLOOD AGAR (November 18, 1985)
  • K854453 — P.E.Z. AGAR (PHENYLETHANOL AGAR) (November 18, 1985)
  • K854275 — THAYER-MARTIN MEDIUM (MOD) (November 12, 1985)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)

FDA data resources