510(k) K892241
K892241 is an FDA 510(k) premarket notification submitted by Sure-Tech Diagnostic Associates, Inc. for the device "FETAL HEMOGLOBIN". The FDA issued a decision of Substantially Equivalent on May 17, 1989. The device falls under product code GHQ (Stain, Fetal Hemoglobin), a Class II device regulated under 21 CFR 864.7455.
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