The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem Tm Hemoglobin Reagent.
| Device ID | K896922 |
| 510k Number | K896922 |
| Device Name: | RAICHEM TM HEMOGLOBIN REAGENT |
| Classification | Cyanomethemoglobin |
| Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Contact | Elsie Shrawder |
| Correspondent | Elsie Shrawder REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
| Product Code | GKK |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-11 |
| Decision Date | 1990-01-25 |