510(k) K812628
K812628 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA FIBRINOGEN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on November 24, 1981. The device falls under product code GFX (Fibrinogen Standard), a Class II device regulated under 21 CFR 864.7340. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1981
- Date Received
- September 15, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fibrinogen Standard
- Device Class
- Class II
- Regulation Number
- 864.7340
- Review Panel
- HE
- Submission Type