510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970933Substantially Equivalent

Auto Hdl Cholesterol Calibrator

Horiba Instruments Incorporated, Lincoln Park MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970933 is the FDA 510(k) clearance record for AUTO HDL CHOLESTEROL CALIBRATOR, a class II device, cleared for Pointe Scientific, Inc., on under FDA product code JIS (Calibrator, Primary). FDA records list 89 510(k) clearances for HORIBA INSTRUMENTS INCORPORATED, from to . As of , FDA records show no recalls naming K970933.

Clearance record

Decision date
Received
(71 days to decision)
Product code
JIS Calibrator, Primary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Pointe Scientific, Inc., 1025 John A. Papalas Dr., Lincoln Park MI
510(k) summary
Statement
Third party review
No

Clearances, product code JIS

Trailing 12 months

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

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