Home / 510(k) Clearances / K932872

510(k) K932872

SICKLE CELL TEST KIT by Histo-Med, Inc. — Product Code JBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1993
Date Received
June 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solubility, Hemoglobin, Abnormal
Device Class
Class II
Regulation Number
864.7825
Review Panel
HE
Submission Type

Other clearances for product code JBB

  • K895745 — SICKLE CELL SOLUBILITY TEST KIT (November 29, 1989)