The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immuglo Anti-endomysial Antibody Ifa.
| Device ID | K060157 |
| 510k Number | K060157 |
| Device Name: | IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120 |
| Contact | Kevin Lawson |
| Correspondent | Kevin Lawson IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 -2120 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-20 |
| Decision Date | 2006-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845714004315 | K060157 | 000 |
| 00845714002199 | K060157 | 000 |
| 00845714002991 | K060157 | 000 |
| 00845714003035 | K060157 | 000 |
| 00845714003318 | K060157 | 000 |
| 00845714003462 | K060157 | 000 |
| 00845714003578 | K060157 | 000 |
| 00845714003585 | K060157 | 000 |
| 00845714003592 | K060157 | 000 |
| 00845714003608 | K060157 | 000 |
| 00845714003943 | K060157 | 000 |
| 00845714003967 | K060157 | 000 |
| 00845714004162 | K060157 | 000 |
| 00845714004179 | K060157 | 000 |
| 00845714004186 | K060157 | 000 |
| 00845714004308 | K060157 | 000 |
| 00845714002175 | K060157 | 000 |