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510(k) K851579

CHOCOLATE MUELLER HINTON AGAR by Preferred Micro-Media — Product Code JTY

K851579 is an FDA 510(k) premarket notification submitted by Preferred Micro-Media for the device "CHOCOLATE MUELLER HINTON AGAR". The FDA issued a decision of Substantially Equivalent on May 8, 1985. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Preferred Micro-Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1985
Date Received
April 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, For Isolation Of Pathogenic Neisseria
Device Class
Class II
Regulation Number
866.2410
Review Panel
MI
Submission Type

Other clearances by Preferred Micro-Media

  • K851594 — SF BROTH (May 14, 1985)
  • K851595 — SIMMONS CITRATE AGAR (May 13, 1985)
  • K851596 — SIM MEDIUM (May 13, 1985)
  • K851593 — SELECTIVE STREPTOCOCCUS AGAR (May 13, 1985)
  • K851597 — TRIPLE SUGAR IRON AGAR (May 13, 1985)
  • K851591 — PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD (May 13, 1985)
  • K851592 — SABOURAUD DEXTROSE AGAR (May 13, 1985)
  • K851598 — THIOGLYCOLLATE WITHOUT INDICATOR (May 10, 1985)
  • K851576 — BIGGY AGAR NICKERSONS MEDIUM (May 9, 1985)
  • K851599 — TRICHOMONAS BROTH (KUPFORBERG (May 8, 1985)

Other clearances for product code JTY

  • K210511 — InTray GC (October 20, 2021)
  • K993033 — INTRAY GC (December 16, 1999)
  • K954986 — GC BASE W/ 1% GCHI (February 16, 1996)
  • K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (June 30, 1995)
  • K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (February 9, 1994)
  • K933121 — MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (February 3, 1994)
  • K934331 — THAYER MARTIN, MODIFIED PILL POCKET (December 21, 1993)
  • K934330 — TRANSGROW (December 17, 1993)
  • K931864 — MARTIN LEWIS WITH LINOCMYCIN (December 15, 1993)
  • K881552 — PROTEOSE NO. 3 AGAR (April 18, 1988)

FDA data resources