The following data is part of a premarket notification filed by Diagnostic Reagent Tech. with the FDA for New Allerg. Coated Microfilter Well Stri.
Device ID | K843302 |
510k Number | K843302 |
Device Name: | NEW ALLERG. COATED MICROFILTER WELL STRI |
Classification | System, Test, Radioallergosorbent (rast) Immunological |
Applicant | DIAGNOSTIC REAGENT TECH. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DHB |
CFR Regulation Number | 866.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-23 |
Decision Date | 1984-10-04 |