510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN190023Unknown

AmplideX Fragile X Dx & Carrier Screen Kit

Asuragen, Inc., Austin TX / Direct, Unknown
FDA source (opens on fda.gov)

DEN190023 is the FDA 510(k) clearance record for AmplideX Fragile X Dx & Carrier Screen Kit, a class II device, cleared for Asuragen, Inc. on under FDA product code OYV (Inherited Nucleotide Repeat Disorder Dna Test). FDA's definition for product code OYV reads: "An inherited nucleotide repeat disorder DNA test is a prescription in vitro diagnostic test that is intended to detect and identify the number of nucleotide repeats in a gene using genomic DNA isolated from post-natal patient specimens. It...". FDA records list 3 510(k) clearances for Asuragen, Inc., from to . As of , FDA records show no recalls naming DEN190023.

Clearance record

Decision date
Received
(309 days to decision)
Product code
OYV Inherited Nucleotide Repeat Disorder Dna Test
Regulation
21 CFR 866.5970
Device class
Class II
Review panel
Immunology
Applicant
Asuragen, Inc. 2150 Woodward, Suite 100, Austin TX
Third party review
No

Clearances, product code OYV

Trailing 12 months

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

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