SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.— 510(k) K890335

Name: FDA 510(k) clearance K890335
Creator: U.S. Food and Drug Administration
Published: 1989-02-17

Substantially Equivalent

Alpkem Corp.

FDA 510(k) clearance K890335 for SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU., Substantially Equivalent on 1989-02-17. Applicant: Alpkem Corp.. Device class: 2.

Clearance details

Applicant: Alpkem Corp.
Product code: Code CGE
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1989-01-23
Decision date: 1989-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

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