The following data is part of a premarket notification filed by Euroimmun Us Llc with the FDA for Euroimmun Ana Ifa: Hep-20-10.
| Device ID | K070763 |
| 510k Number | K070763 |
| Device Name: | EUROIMMUN ANA IFA: HEP-20-10 |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | EUROIMMUN US LLC 429 ROCKAWAY VALLEY ROAD UNIT 1200 Boonton Township, NJ 07005 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US LLC 429 ROCKAWAY VALLEY ROAD UNIT 1200 Boonton Township, NJ 07005 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-20 |
| Decision Date | 2007-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016045403 | K070763 | 000 |
| 04049016045397 | K070763 | 000 |
| 04049016045380 | K070763 | 000 |
| 04049016045366 | K070763 | 000 |
| 04049016045359 | K070763 | 000 |
| 04049016045335 | K070763 | 000 |