510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132978Substantially Equivalent

Impact Dx Factor V Leiden and Factor II Genotyping Test

Sequenom, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132978 is the FDA 510(k) clearance record for IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST, a class II device, cleared for Sequenom, Inc. on under FDA product code PHJ (System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations). FDA's definition for product code PHJ reads: "A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in...". FDA records list one 510(k) clearance for Sequenom, Inc. As of , FDA records show no recalls naming K132978.

Clearance record

Decision date
Received
(263 days to decision)
Product code
PHJ System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
Regulation
21 CFR 864.7280
Device class
Class II
Review panel
Hematology
Applicant
Sequenom, Inc. 3595 John Hopkins Ct., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHJ

Trailing 12 months

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

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