510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955283Substantially Equivalent

Primus Variant System Pvs99

Trinity Biotech (Primus Corporation dba Trinity Biotech), Kansas City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955283 is the FDA 510(k) clearance record for PRIMUS VARIANT SYSTEM PVS99, a class II device, cleared for Primus Corp. on under FDA product code GKA (Abnormal Hemoglobin Quantitation). FDA records list 16 510(k) clearances for Trinity Biotech (Primus Corporation dba Trinity Biotech), from to . As of , FDA records show one recall naming K955283.

Clearance record

Decision date
Received
(106 days to decision)
Product code
GKA Abnormal Hemoglobin Quantitation
Regulation
21 CFR 864.7415
Device class
Class II
Review panel
Hematology
Applicant
Primus Corp. P.O. Box 22599, Kansas City MO
510(k) summary
Statement
Third party review
No

Clearances, product code GKA

Trailing 12 months

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

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