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510(k) K950196

CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA by Bioclinical Systems, Inc. — Product Code JTY

K950196 is an FDA 510(k) premarket notification submitted by Bioclinical Systems, Inc. for the device "CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA". The FDA issued a decision of Substantially Equivalent on June 30, 1995. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Bioclinical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1995
Date Received
January 18, 1995
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 Bioclinical Systems, Inc.

  • K945911 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (April 4, 1995)
  • K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (February 9, 1994)
  • K933121 — MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (February 3, 1994)
  • K873086 — ROUND 1 (August 24, 1987)
  • K860334 — VISI-CHECK HLH TEST MONOCLONAL (April 21, 1986)
  • K860333 — MICRO-ELISA HLH TEST KIT MONOCLONAL (April 21, 1986)
  • K855227 — MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL (April 11, 1986)
  • K854059 — MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO (January 13, 1986)
  • K854379 — MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT (January 7, 1986)
  • K850079 — NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG (March 5, 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)
  • 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)
  • K881527 — CASMAN MEDIUM BASE (April 18, 1988)

FDA data resources