510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973588Substantially Equivalent

Liquid Alkaline Phoshatase Reagent Set

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

K973588 is the FDA 510(k) clearance record for LIQUID ALKALINE PHOSHATASE REAGENT SET, a class II device, cleared for Pointe Scientific, Inc., on under FDA product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes). FDA records list 89 510(k) clearances for HORIBA INSTRUMENTS INCORPORATED, from to . As of , FDA records show 18 recalls naming K973588.

Clearance record

Decision date
Received
(30 days to decision)
Product code
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Regulation
21 CFR 862.1050
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 CJE

Trailing 12 months
1 clearance under product code CJE in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CJE, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260