MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON— 510(k) K852568

Name: FDA 510(k) clearance K852568
Creator: U.S. Food and Drug Administration
Published: 1985-07-12

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K852568 for MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON, Substantially Equivalent on 1985-07-12. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code KIT
Device class: Class 1
Regulation: 21 CFR 864.2220
Advisory panel: Hematology
Date received: 1985-06-18
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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