The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Spia(tm) Igg Reagents.
| Device ID | K894416 |
| 510k Number | K894416 |
| Device Name: | RAICHEM(TM) SPIA(TM) IGG REAGENTS |
| Classification | Reagent, Immunoassay, Igg |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | J Shrawder,phd |
| Correspondent | J Shrawder,phd REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | KTO |
| CFR Regulation Number | 866.5530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-08-01 |