510(k) K932872
K932872 is an FDA 510(k) premarket notification submitted by Histo-Med, Inc. for the device "SICKLE CELL TEST KIT". The FDA issued a decision of Substantially Equivalent on Aug 16, 1993. The device falls under product code JBB (Solubility, Hemoglobin, Abnormal), a Class II device regulated under 21 CFR 864.7825.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 16, 1993
- Date Received
- Jun 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
- 510(k)