The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem (tm) Spia (tm) - Acid Glycoprotein Reagent.
| Device ID | K904175 |
| 510k Number | K904175 |
| Device Name: | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT |
| Classification | Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | Norbert Neumann |
| Correspondent | Norbert Neumann REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | LKL |
| CFR Regulation Number | 866.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-11 |
| Decision Date | 1990-11-13 |