510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063787Substantially Equivalent

Inplex Cf Molecular Test

Third Wave Technologies, Inc., Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063787 is the FDA 510(k) clearance record for INPLEX CF MOLECULAR TEST, a class II device, cleared for Third Wave Technologies, Inc. on under FDA product code NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection). FDA's definition for product code NUA reads: "The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected...". FDA records list 2 510(k) clearances for Third Wave Technologies, Inc., from to . As of , FDA records show one recall naming K063787.

Clearance record

Decision date
Received
(448 days to decision)
Product code
NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Regulation
21 CFR 866.5900
Device class
Class II
Review panel
Immunology
Applicant
Third Wave Technologies, Inc. 502 S. Rosa Rd., Madison WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUA

Trailing 12 months

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

FDA records show no clearances under product code NUA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NUA, 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