DeviceClearance

CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM— 510(k) K925668

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K925668 for CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM, Substantially Equivalent on 1992-12-28. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant
E.I. Dupont DE Nemours & Co., Inc.
Product code
Code CGX
Device class
Class 2
Regulation
21 CFR 862.1225
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wilmington, DE, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K925668

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925668.

Data sourced from openFDA. This site is unofficial and independent of the FDA.