K844836 is an FDA 510(k) clearance for the HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER. This device is classified as a Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp (Class II - Special Controls, product code GWD).
Submitted by Edward Weck, Inc. (Research Triangle Pa, US). The FDA issued a Cleared decision on January 23, 1985, 42 days after receiving the submission on December 12, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3220.
| 510(k) Number | K844836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1984 |
| Decision Date | January 23, 1985 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GWD — Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3220 |