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510(k) K850841

MOD THAYER MARTIN MARTIN LEWIS by Micro Media Laboratories — Product Code JTY

K850841 is an FDA 510(k) premarket notification submitted by Micro Media Laboratories for the device "MOD THAYER MARTIN MARTIN LEWIS". The FDA issued a decision of Substantially Equivalent on March 20, 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. Micro Media Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
March 1, 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 Micro Media Laboratories

  • K853691 — TERGITOL 7 AGAR (September 17, 1985)
  • K853690 — COLUMBIZ BLOOD AGAR (September 17, 1985)
  • K851344 — OXIDATIVE FORMENTIVE MEDIUM (April 22, 1985)
  • K851346 — PHENYLALANINE AGAR (April 19, 1985)
  • K851345 — PURPLE BROTH (April 19, 1985)
  • K851347 — KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR (April 19, 1985)
  • K851343 — BROM CRESOL PURPLE STARCH (April 19, 1985)
  • K851348 — COBA AGAR (April 19, 1985)
  • K850844 — V AGAR (March 20, 1985)
  • K850847 — THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN (March 20, 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