510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981978Substantially Equivalent

Autoldl Cholesterol Reagent Set and Autoldl Cholesterol Calibrator

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

K981978 is the FDA 510(k) clearance record for AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR, a class I device, cleared for Pointe Scientific, Inc., on under FDA product code MRR (System, Test, Low Density, Lipoprotein). FDA records list 89 510(k) clearances for HORIBA INSTRUMENTS INCORPORATED, from to . As of , FDA records show no recalls naming K981978.

Clearance record

Decision date
Received
(47 days to decision)
Product code
MRR System, Test, Low Density, Lipoprotein
Regulation
21 CFR 862.1475
Device class
Class I
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 MRR

Trailing 12 months

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

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