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510(k) K834065

A3B by Remel Co. — Product Code JSN

K834065 is an FDA 510(k) premarket notification submitted by Remel Co. for the device "A3B". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code JSN (Culture Media, Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Remel Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
November 25, 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 Remel Co.

  • K162620 — Remel Spectra ESBL (May 1, 2017)
  • K131804 — REMEL XPECT FLU A&B (July 12, 2013)
  • K092407 — REMEL SPECTRA MRSA (October 8, 2010)
  • K072827 — RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE (November 26, 2007)
  • 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)
  • K961756 — CYTOQUANT VIRAL TRANSPORT MEDIUM (May 17, 1996)
  • K961755 — CYTOQUANT CHLAMYDIA 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)
  • K831186 — RAPID NFT (May 9, 1983)

FDA data resources