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510(k) K831186

RAPID NFT by Dms Laboratories — Product Code JSN

K831186 is an FDA 510(k) premarket notification submitted by Dms Laboratories for the device "RAPID NFT". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code JSN (Culture Media, Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Dms Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
April 12, 1983
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 Dms Laboratories

  • K831187 — TRP (May 9, 1983)
  • K830437 — CHS (March 17, 1983)
  • K823102 — AGAR P (December 3, 1982)
  • K821038 — FAST VIOLET B (May 27, 1982)
  • K813612 — RAPID ZYME (February 22, 1982)
  • K813613 — RAPID CH (February 22, 1982)
  • K820210 — IND (February 12, 1982)
  • K820211 — NINHYDRIN (February 12, 1982)
  • K820213 — SALINE SOLUTION (February 12, 1982)
  • K820212 — OXI (February 12, 1982)

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)
  • K841208 — PROPAGATING TRANSPORT (April 5, 1984)
  • K833968 — 10B (December 30, 1983)
  • K834065 — A3B (December 27, 1983)

FDA data resources