The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad Rast Reagents.
Device ID | K820029 |
510k Number | K820029 |
Device Name: | KALLESTAD RAST REAGENTS |
Classification | System, Test, Radioallergosorbent (rast) Immunological |
Applicant | KALLESTAD LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DHB |
CFR Regulation Number | 866.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-05 |
Decision Date | 1982-04-06 |