Submission Details
| 510(k) Number | K172745 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 12, 2017 |
| Decision Date | June 05, 2018 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ImmuGlo HEp-2 Elite IFA
Jun 2018
Decision
266d
Days
Class 2
Risk
About This 510(k) Submission
K172745 is an FDA 510(k) clearance for the ImmuGlo HEp-2 Elite IFA, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on June 5, 2018, 266 days after receiving the submission on September 12, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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