510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061301Substantially Equivalent

Copan Liquid Amies Elution Swab (Eswab) Collection and Transport System

COPAN Diagnostics, Inc., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061301 is the FDA 510(k) clearance record for COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM, a class I device, cleared for Copan Diagnostics, Inc. on under FDA product code JTW (System, Transport, Aerobic). FDA records list 10 510(k) clearances for Copan Diagnostics, Inc., from to . As of , FDA records show no recalls naming K061301.

Clearance record

Decision date
Received
(44 days to decision)
Product code
JTW System, Transport, Aerobic
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Copan Diagnostics, Inc. 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JTW

Trailing 12 months

FDA records hold no clearances under product code JTW in the trailing twelve months.

FDA records show no clearances under product code JTW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JTW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260