HANKS' BALANCED SALTS (HBSS) NO. H1387— 510(k) K870484

Name: FDA 510(k) clearance K870484
Creator: U.S. Food and Drug Administration
Published: 1987-03-30

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K870484 for HANKS' BALANCED SALTS (HBSS) NO. H1387, Substantially Equivalent on 1987-03-30. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code KIP
Device class: Class 1
Regulation: 21 CFR 864.2875
Advisory panel: Hematology
Date received: 1987-02-03
Decision date: 1987-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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