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510(k) K800333

MODIFIED THAYER-MARTIN X AGAR by Isle Media and Sterile Products, Inc. — Product Code JTY

K800333 is an FDA 510(k) premarket notification submitted by Isle Media and Sterile Products, Inc. for the device "MODIFIED THAYER-MARTIN X AGAR". The FDA issued a decision of Substantially Equivalent on March 3, 1980. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Isle Media and Sterile Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1980
Date Received
February 14, 1980
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 Isle Media and Sterile Products, Inc.

  • K831671 — MODIFIED SOYBEAN CASEIN DIGEST BROTH (July 28, 1983)
  • K821218 — CAMPY-S AGAR (May 14, 1982)
  • K820863 — MEDIA FOR IN-VITRO DIAGNOSTIC USE (April 16, 1982)
  • K812797 — SCHAEDLER AGARS (October 20, 1981)
  • K812796 — ANAEROBIC CNA BLOOD AGAR (October 20, 1981)
  • K812795 — ANAEROBIC BLOOD AGAR (October 20, 1981)
  • K812798 — MOTILITY GI MEDIUM (October 20, 1981)
  • K800807 — CORN MEAL AGAR MEDIA (April 24, 1980)
  • K800818 — CHLAMYDOSPORE AGAR (April 24, 1980)
  • K800334 — MARTIN-LEWIS AGAR (March 3, 1980)

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