510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062028Substantially Equivalent

Cystic Fibrosis Genotyping Assay, Model 6L20-01

Celera Diagnostics, Alameda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062028 is the FDA 510(k) clearance record for CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01, a class II device, cleared for Celera Diagnostics 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 one 510(k) clearance for Celera Diagnostics. As of , FDA records show no recalls naming K062028.

Clearance record

Decision date
Received
(416 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
Celera Diagnostics 1401 Harbor Bay Pkwy., Alameda CA
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