510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K902083Substantially Equivalent

Chrom-Trol Cat. No. 5300 W/ New Analyte

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

K902083 is the FDA 510(k) clearance record for CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE, a class II device, cleared for Helena Laboratories on under FDA product code GJT (Plasma, Coagulation Factor Deficient). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K902083.

Clearance record

Decision date
Received
(39 days to decision)
Product code
GJT Plasma, Coagulation Factor Deficient
Regulation
21 CFR 864.7290
Device class
Class II
Review panel
Hematology
Applicant
Helena Laboratories 1530 Lindbergh Dr., Beaumont TX
Third party review
No

Clearances, product code GJT

Trailing 12 months

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

FDA records show no clearances under product code GJT in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GJT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260