510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192931Substantially Equivalent

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control

Helena Laboratories, Corp., Beaumont TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192931 is the FDA 510(k) clearance record for V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control, a class II device, cleared for Helena Laboratories, Corp. on under FDA product code GKA (Abnormal Hemoglobin Quantitation). FDA records list 282 510(k) clearances for Helena Laboratories, Corp., from to . As of , FDA records show no recalls naming K192931.

Clearance record

Decision date
Received
(915 days to decision)
Product code
GKA Abnormal Hemoglobin Quantitation
Regulation
21 CFR 864.7415
Device class
Class II
Review panel
Hematology
Applicant
Helena Laboratories, Corp. 1530 Lingbergh Dr., Beaumont TX
510(k) summary
Summary PDF
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