FETAL HEMOGLOBIN— 510(k) K892241

Name: FDA 510(k) clearance K892241
Creator: U.S. Food and Drug Administration
Published: 1989-05-17

Substantially Equivalent

Sure-Tech Diagnostic Associates, Inc.

FDA 510(k) clearance K892241 for FETAL HEMOGLOBIN, Substantially Equivalent on 1989-05-17. Applicant: Sure-Tech Diagnostic Associates, Inc.. Device class: 2.

Clearance details

Applicant: Sure-Tech Diagnostic Associates, Inc.
Product code: Code GHQ
Device class: Class 2
Regulation: 21 CFR 864.7455
Advisory panel: Hematology
Date received: 1989-03-22
Decision date: 1989-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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