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510(k) K782117

MARTIN-LEWIS MEDIUM by Prepared Media Laboratory, Inc. — Product Code JTY

K782117 is an FDA 510(k) premarket notification submitted by Prepared Media Laboratory, Inc. for the device "MARTIN-LEWIS MEDIUM". The FDA issued a decision of Substantially Equivalent on February 1, 1979. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Prepared Media Laboratory, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1979
Date Received
December 27, 1978
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 Prepared Media Laboratory, Inc.

  • K962744 — HAEMOPHILUS TEST MEDIUM AGAR (HTM) (October 15, 1996)
  • K962745 — ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) (October 2, 1996)

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