The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Rapitex(r) Asl New.
| Device ID | K903854 |
| 510k Number | K903854 |
| Device Name: | RAPITEX(R) ASL NEW |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-21 |
| Decision Date | 1991-01-28 |