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510(k) K860384

BIOTIS MODIFIED THAYER MARTIN by Otisville Biotech, Inc. — Product Code JTY

K860384 is an FDA 510(k) premarket notification submitted by Otisville Biotech, Inc. for the device "BIOTIS MODIFIED THAYER MARTIN". The FDA issued a decision of Substantially Equivalent on February 24, 1986. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Otisville Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1986
Date Received
February 3, 1986
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 Otisville Biotech, Inc.

  • K862392 — BIOTIS MOTILITY TEST MEDIUM (July 3, 1986)
  • K862391 — BIOTIS DESOXYCHOLATE AGAR (July 3, 1986)
  • K862400 — BIOTIS KV LAKED BLOOD AGAR (July 3, 1986)
  • K862396 — BIOTIS DECARBOXYLASE MEDIA, ARGININE (July 3, 1986)
  • K862388 — BIOTIS TCBS AGAR (July 3, 1986)
  • K862398 — BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (July 3, 1986)
  • K862390 — BIOTIS BORDET GENGOU AGAR (July 3, 1986)
  • K862389 — BIOTIS ACETAMIDE AGAR (July 3, 1986)
  • K862395 — BIOTIS DECARBOXYLASE MEDIA, BASE (July 3, 1986)
  • K862387 — BIOTIS HAEMOPHILUS IDENTIFICATION QUAD (July 3, 1986)

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