The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Bilirubin Conjugate Standard.
| Device ID | K883389 |
| 510k Number | K883389 |
| Device Name: | RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD |
| Classification | Calibrator, Surrogate |
| 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 | JIW |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-10 |
| Decision Date | 1988-12-14 |