The following data is part of a premarket notification filed by Euroimmun U.s., Inc. with the FDA for Euroimmun Ifa 40: Hep-20-10; Europattern Microscope And Software.
| Device ID | K141827 |
| 510k Number | K141827 |
| Device Name: | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | EUROIMMUN U.S., Inc. 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Contact | Michael A Locke |
| Correspondent | Michael A Locke EUROIMMUN U.S., Inc. 1100 THE AMERICAN ROAD Morris Plains, NJ 07950 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2015-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016135739 | K141827 | 000 |
| 04049016100560 | K141827 | 000 |
| 04049016099451 | K141827 | 000 |
| 04049016099444 | K141827 | 000 |
| 04049016099437 | K141827 | 000 |
| 04049016099420 | K141827 | 000 |
| 04049016099413 | K141827 | 000 |