510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043576Substantially Equivalent

Roche Amplichip Cyp450 Test

Roche Molecular Systems Inc, Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043576 is the FDA 510(k) clearance record for ROCHE AMPLICHIP CYP450 TEST, a class II device, cleared for Roche Molecular Systems, Inc. on under FDA product code NTI (Drug Metabolizing Enzyme Genotyping Systems). FDA's definition for product code NTI reads: "Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and...". FDA records list 53 510(k) clearances for Roche Molecular Systems, Inc., from to . As of , FDA records show one recall naming K043576.

Clearance record

Decision date
Received
(14 days to decision)
Product code
NTI Drug Metabolizing Enzyme Genotyping Systems
Regulation
21 CFR 862.3360
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Molecular Systems, Inc. 4300 Hacienda Dr., Pleasanton CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTI

Trailing 12 months

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

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