The following data is part of a premarket notification filed by Euroimmun Us Llc with the FDA for Euroimmun Endomysium Ifa: Esophagus (monkey) Kit.
| Device ID | K061408 |
| 510k Number | K061408 |
| Device Name: | EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | EUROIMMUN US LLC 429 ROCKAWAY VALLEY RD. UNIT 1200 Boonton Twp, NJ 07005 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US LLC 429 ROCKAWAY VALLEY RD. UNIT 1200 Boonton Twp, NJ 07005 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-22 |
| Decision Date | 2006-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016119999 | K061408 | 000 |
| 04049016048596 | K061408 | 000 |
| 04049016048602 | K061408 | 000 |
| 04049016048619 | K061408 | 000 |
| 04049016048626 | K061408 | 000 |
| 04049016075134 | K061408 | 000 |
| 04049016087069 | K061408 | 000 |
| 04049016119951 | K061408 | 000 |
| 04049016119968 | K061408 | 000 |
| 04049016119975 | K061408 | 000 |
| 04049016119982 | K061408 | 000 |
| 04049016144595 | K061408 | 000 |