The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Seralyzer(r) Therapeutic Drug Assay Control(abnor).
| Device ID | K921939 |
| 510k Number | K921939 |
| Device Name: | SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) |
| Classification | Drug Specific Control Materials |
| Applicant | HERAEUS KULZER, INC. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
| Contact | Rosanne M Savol |
| Correspondent | Rosanne M Savol HERAEUS KULZER, INC. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-24 |
| Decision Date | 1992-07-16 |