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510(k) K832612

CHOCOLATE AGAR & THAYER MARTIN AGAR by Carroll Biological Corp. — Product Code JTY

K832612 is an FDA 510(k) premarket notification submitted by Carroll Biological Corp. for the device "CHOCOLATE AGAR & THAYER MARTIN AGAR". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Carroll Biological Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 8, 1983
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 Carroll Biological Corp.

  • K832243 — CULTURE MEDIUM FOR ANTIMICROBIAL SUS (September 29, 1983)
  • K832611 — TRYPTIC SOY AGAR (September 12, 1983)
  • K832620 — TRYPTIC SOY BROTH MEDIA (September 12, 1983)
  • K832618 — BLUE AGAR (September 12, 1983)
  • K832614 — SELENITE BROTH (September 12, 1983)
  • K832619 — THIOGLYCOLLATE MEDIUM (September 12, 1983)
  • K832613 — MANNITOL SALT AGAR (September 12, 1983)
  • K832616 — MACCONKEY AGAR MEDIA (September 12, 1983)
  • K832617 — XYLOSE LYSINE DEOXYCHOLATE (September 12, 1983)
  • K832615 — SF BROTH (September 12, 1983)

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