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510(k) K853237

APL MARTIN LEWIS MEDIUM by Apl Medical Supplies — Product Code JTY

K853237 is an FDA 510(k) premarket notification submitted by Apl Medical Supplies for the device "APL MARTIN LEWIS MEDIUM". The FDA issued a decision of Substantially Equivalent on August 19, 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. Apl Medical Supplies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1985
Date Received
August 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 Apl Medical Supplies

  • K853610 — APL MOTILITY INDOLE ORNITHINE AGAR (September 16, 1985)
  • K853618 — APL SIM MEDIUM (September 16, 1985)
  • K853619 — APL TRIPLE SUGAR IRON AGAR (September 16, 1985)
  • K853617 — APL SIMMONS CITRATE AGAR (September 16, 1985)
  • K853611 — APL XYLOSE LYSINE DEOXYCHOLATE AGAR (September 12, 1985)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K853612 — APL DNASE TEST AGAR (September 6, 1985)
  • K853613 — APL GN BROTH (September 6, 1985)
  • K853616 — APL CHLAMYDOSPORE AGAR (September 6, 1985)
  • K853615 — APL BILE ESCULIN/AZIDE AGAR (September 6, 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