The following data is part of a premarket notification filed by Immuno Probe, Inc. with the FDA for Pr-3 Elisa Test System.
| Device ID | K961764 |
| 510k Number | K961764 |
| Device Name: | PR-3 ELISA TEST SYSTEM |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | IMMUNO PROBE, INC. 1306F BAILES LN. Frederick, MD 21701 |
| Contact | William L Boteler Jr. |
| Correspondent | William L Boteler Jr. IMMUNO PROBE, INC. 1306F BAILES LN. Frederick, MD 21701 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-07 |
| Decision Date | 1996-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516743891 | K961764 | 000 |