510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K932768Substantially Equivalent

Cardio Rep Ck Calibrators 1 & 2 Cat. No. 3322 & 3323

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

K932768 is the FDA 510(k) clearance record for CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323, a class II device, cleared for Helena Laboratories on under FDA product code JIX (Calibrator, Multi-Analyte Mixture). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K932768.

Clearance record

Decision date
Received
(132 days to decision)
Product code
JIX Calibrator, Multi-Analyte Mixture
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Helena Laboratories 1530 Lindbergh Dr., Beaumont TX
510(k) summary
Statement
Third party review
No

Clearances, product code JIX

Trailing 12 months

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

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