510(k) K914226
K914226 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK". The FDA issued a decision of Substantially Equivalent on November 19, 1991. The device falls under product code JZB (Scissors, Ear), a Class I device regulated under 21 CFR 874.4420. 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 19, 1991
- Date Received
- September 20, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scissors, Ear
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type