510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K982767Substantially Equivalent

Raichem Hdl-Cholesterol Direct Reagent, Hdl-Cholesterol Calibrator

Raichem, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982767 is the FDA 510(k) clearance record for RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR, a class II device, cleared for Raichem on under FDA product code JIX (Calibrator, Multi-Analyte Mixture). FDA records list one 510(k) clearance for Raichem. As of , FDA records show no recalls naming K982767.

Clearance record

Decision date
Received
(46 days to decision)
Product code
JIX Calibrator, Multi-Analyte Mixture
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Raichem 8225 Mercury Ct., San Diego CA
510(k) summary
Summary
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIX, 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