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510(k) K934330

TRANSGROW by Hardy Diagnostics — Product Code JTY

K934330 is an FDA 510(k) premarket notification submitted by Hardy Diagnostics for the device "TRANSGROW". The FDA issued a decision of Substantially Equivalent on December 17, 1993. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Hardy Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1993
Date Received
September 3, 1993
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 Hardy Diagnostics

  • K260842 — HardyDisk AST Gepotidacin 10µg (GEP10) (May 11, 2026)
  • K253105 — HardyDisk AST Cefiderocol 30µg (FDC30) (November 20, 2025)
  • K250956 — HardyDisk AST Gepotidacin 10µg (GEP10) (June 26, 2025)
  • K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (May 15, 2025)
  • K233534 — Viral Transport Medium (August 2, 2024)
  • K241060 — HardyDisk AST Cefiderocol 30µg (FDC30) (July 18, 2024)
  • K231568 — HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) (July 6, 2023)
  • K230827 — HardyDisk AST Rezafungin 5µg (RZF5) (June 1, 2023)
  • K193504 — HardyDisk AST Cefiderocol 30ug (FDC30) (January 23, 2020)
  • K192326 — HardyDisk AST Lefamulin 20µg (LMU20) (September 19, 2019)

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)
  • K931864 — MARTIN LEWIS WITH LINOCMYCIN (December 15, 1993)
  • K881552 — PROTEOSE NO. 3 AGAR (April 18, 1988)
  • K881527 — CASMAN MEDIUM BASE (April 18, 1988)

FDA data resources