The following data is part of a premarket notification filed by Wiener Laboratories S.a.i.c. with the FDA for Wiener Lab. Amilasa 405 Cinetica Aa, Wiener Lab.amilasa 405 Cinetica Unitest,wiener Lab.amilasa Cinetica Aa.
| Device ID | K013101 |
| 510k Number | K013101 |
| Device Name: | WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA |
| Classification | Catalytic Methods, Amylase |
| Applicant | WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA Rosario, AR 2000 |
| Contact | Viviana Cetola |
| Correspondent | Viviana Cetola WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA Rosario, AR 2000 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-17 |
| Decision Date | 2001-11-16 |
| Summary: | summary |