The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Immuglo Anti-neutrophil Cytoplasmic Antibody (anca) Test Sytem.
| Device ID | K982898 |
| 510k Number | K982898 |
| Device Name: | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Contact | Kevin J Lawson |
| Correspondent | Kevin J Lawson IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. Buffalo, NY 14228 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-17 |
| Decision Date | 1998-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817022357 | K982898 | 000 |
| 00847817016103 | K982898 | 000 |
| 00847817016097 | K982898 | 000 |
| 00847817016080 | K982898 | 000 |
| 00845714004001 | K982898 | 000 |
| 00845714003851 | K982898 | 000 |
| 00845714003776 | K982898 | 000 |
| 00845714003769 | K982898 | 000 |
| 00845714003752 | K982898 | 000 |
| 00845714003387 | K982898 | 000 |
| 00847817016110 | K982898 | 000 |
| 00847817016127 | K982898 | 000 |
| 00847817016134 | K982898 | 000 |
| 00847817020162 | K982898 | 000 |
| 00847817016233 | K982898 | 000 |
| 00847817016219 | K982898 | 000 |
| 00847817016196 | K982898 | 000 |
| 00847817016189 | K982898 | 000 |
| 00847817016172 | K982898 | 000 |
| 00847817016165 | K982898 | 000 |
| 00847817016158 | K982898 | 000 |
| 00847817016141 | K982898 | 000 |
| 00845714003370 | K982898 | 000 |