510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061377Substantially Equivalent

Apolipoprotein A1 and Apolipoprotein B Reagents and Calibrators

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

K061377 is the FDA 510(k) clearance record for APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS, a class I device, cleared for Pointe Scientific, Inc., on under FDA product code MSJ (Apolipoproteins). FDA records list 89 510(k) clearances for HORIBA INSTRUMENTS INCORPORATED, from to . As of , FDA records show no recalls naming K061377.

Clearance record

Decision date
Received
(315 days to decision)
Product code
MSJ Apolipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Pointe Scientific, Inc., 5449 Research Dr., Lincoln Park MI
510(k) summary
Statement
Third party review
No

Clearances, product code MSJ

Trailing 12 months

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

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