510(k) K874429
K874429 is an FDA 510(k) premarket notification submitted by Hf Scientific, Inc. for the device "HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12". The FDA issued a decision of Substantially Equivalent on February 4, 1988. The device falls under product code GIQ (Hemoglobin S), a Class II device regulated under 21 CFR 864.7415. Hf Scientific, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1988
- Date Received
- October 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobin S
- Device Class
- Class II
- Regulation Number
- 864.7415
- Review Panel
- HE
- Submission Type