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510(k) K833968

10B by Remel Co. — Product Code JSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1983
Date Received
November 16, 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

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  • K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (November 15, 2004)
  • K033479 — PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (February 26, 2004)
  • K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (November 18, 2003)
  • K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (November 14, 2003)
  • K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (November 10, 2003)
  • K031565 — XPECT INFLUENZA A/B (July 17, 2003)

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)
  • K834065 — A3B (December 27, 1983)
  • K831186 — RAPID NFT (May 9, 1983)