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 |