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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 Sep 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 10 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 12, 1983
Date Received
Jul 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
510(k)

Other clearances by Carroll Biological Corp.

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

Other clearances for product code JTY

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

FDA data resources

Source: FDA 510(k) database entry for K832612. Report a data issue: hello@regdatalab.com.