The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Anti-reticulin Antibody (ara) Test.
| Device ID | K913360 |
| 510k Number | K913360 |
| Device Name: | ANTI-RETICULIN ANTIBODY (ARA) TEST |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Contact | Susan Krasny |
| Correspondent | Susan Krasny IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1994-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845714003974 | K913360 | 000 |
| 00845714003653 | K913360 | 000 |