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510(k) K841208

PROPAGATING TRANSPORT by Smith River Biologicals — Product Code JSN

K841208 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "PROPAGATING TRANSPORT". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code JSN (Culture Media, Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Smith River Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1984
Date Received
March 12, 1984
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 Smith River Biologicals

  • K923892 — SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA (June 21, 1993)
  • K841207 — NON-SELECTIVE & NON-DIFFERENTIAL (April 17, 1984)
  • K841206 — NON-SELECTIVE & DIFFERENTIAL (April 17, 1984)
  • K841204 — MULTIPLE BIOCHEMICAL TEST (April 17, 1984)
  • K841209 — SELECTIVE AND DIFFERENTIAL (April 17, 1984)
  • K841211 — SELECTIVE BROTH (April 5, 1984)
  • K841213 — ANTIMICROBIAL SUSCEPT-CULTURE MEDIA (April 4, 1984)
  • K841205 — NON PROPAGATING TRANSPORT (April 4, 1984)
  • K841212 — SINGLE BIOCHEMICAL TEST (April 4, 1984)
  • K841203 — GENERAL NUTRIENT BROTH (April 4, 1984)

Other clearances for product code JSN

  • K000718 — CHROMOSTREAK (August 24, 2000)
  • K962745 — ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) (October 2, 1996)
  • K961755 — CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM (May 17, 1996)
  • K961756 — CYTOQUANT VIRAL TRANSPORT MEDIUM (May 17, 1996)
  • K896296 — INPOUCH-TV POUCH (January 29, 1990)
  • K881579 — AMIES TRANSPORT MEDIUM W/O CHARCOAL (April 18, 1988)
  • K860967 — VIRTRAN VIRAL TRANSPORTER (MODIFIED) (April 4, 1986)
  • K833968 — 10B (December 30, 1983)
  • K834065 — A3B (December 27, 1983)
  • K831186 — RAPID NFT (May 9, 1983)

FDA data resources