The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantafluor Fluorescent Test Reagents.
| Device ID | K813592 |
| 510k Number | K813592 |
| Device Name: | QUANTAFLUOR FLUORESCENT TEST REAGENTS |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-28 |
| Decision Date | 1982-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847865001724 | K813592 | 000 |
| 00847865001717 | K813592 | 000 |
| 00847865001700 | K813592 | 000 |
| 00847865001694 | K813592 | 000 |