510(k) K844836
K844836 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER". The FDA issued a decision of Substantially Equivalent on January 23, 1985. The device falls under product code GWD (Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp), a Class II device regulated under 21 CFR 866.3220. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1985
- Date Received
- December 12, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
- Device Class
- Class II
- Regulation Number
- 866.3220
- Review Panel
- MI
- Submission Type