510(k) K854687
K854687 is an FDA 510(k) premarket notification submitted by Future Impex Corp. for the device "ERMA HB-METER MODEL 303N". The FDA issued a decision of Substantially Equivalent on June 4, 1986. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Future Impex Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 1986
- Date Received
- November 20, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Whole Blood Hemoglobin Determination
- Device Class
- Class II
- Regulation Number
- 864.7500
- Review Panel
- HE
- Submission Type