The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Spia(tm) Haptoglobin Reagent.
| Device ID | K911898 |
| 510k Number | K911898 |
| Device Name: | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT |
| Classification | Haptoglobin, Antigen, Antiserum, Control |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | Alfred E.peacock,jr. |
| Correspondent | Alfred E.peacock,jr. REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | DAD |
| CFR Regulation Number | 866.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-26 |
| Decision Date | 1991-05-08 |