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510(k) K892241

FETAL HEMOGLOBIN by Sure-Tech Diagnostic Associates, Inc. — Product Code GHQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1989
Date Received
March 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stain, Fetal Hemoglobin
Device Class
Class II
Regulation Number
864.7455
Review Panel
HE
Submission Type

Other clearances for product code GHQ

  • K990641 — CALTAG FETAL HEMOGLOBIN TEST (September 17, 1999)