510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001387Substantially Equivalent

I-Stat Portable Clinical Analyzer, Model 300

I-Stat Corp., East Windsor NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001387 is the FDA 510(k) clearance record for I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300, a class II device, cleared for I-Stat Corp. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list 21 510(k) clearances for I-Stat Corp., from to . As of , FDA records show 13 recalls naming K001387.

Clearance record

Decision date
Received
(156 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
I-Stat Corp. 104 Windsor Center Dr., East Windsor NJ
510(k) summary
Summary
Third party review
No

Clearances, product code CGA

Trailing 12 months
1 clearance under product code CGA in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260