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510(k) K896296

INPOUCH-TV POUCH by Biomed Diagnostics, Inc. — Product Code JSN

K896296 is an FDA 510(k) premarket notification submitted by Biomed Diagnostics, Inc. for the device "INPOUCH-TV POUCH". The FDA issued a decision of Substantially Equivalent on January 29, 1990. The device falls under product code JSN (Culture Media, Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Biomed Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1990
Date Received
October 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type

Other clearances by Biomed Diagnostics, Inc.

  • K993033 — INTRAY GC (December 16, 1999)

Other clearances for product code JSN

  • K000718 — CHROMOSTREAK (August 24, 2000)
  • K962745 — ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) (October 2, 1996)
  • K961756 — CYTOQUANT VIRAL TRANSPORT MEDIUM (May 17, 1996)
  • K961755 — CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM (May 17, 1996)
  • K881579 — AMIES TRANSPORT MEDIUM W/O CHARCOAL (April 18, 1988)
  • K860967 — VIRTRAN VIRAL TRANSPORTER (MODIFIED) (April 4, 1986)
  • K841208 — PROPAGATING TRANSPORT (April 5, 1984)
  • K833968 — 10B (December 30, 1983)
  • K834065 — A3B (December 27, 1983)
  • K831186 — RAPID NFT (May 9, 1983)

FDA data resources