The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Ats 0.2% Bovine Albumin Fraction V Solution.
| Device ID | K880990 |
| 510k Number | K880990 |
| Device Name: | ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION |
| Classification | Kit, Identification, Mycobacteria |
| Applicant | ALPHA-TEC SYSTEMS, INC. 18271 MCDURMOTT WEST, STE I Irvine, CA 92714 |
| Contact | Laurie Williams |
| Correspondent | Laurie Williams ALPHA-TEC SYSTEMS, INC. 18271 MCDURMOTT WEST, STE I Irvine, CA 92714 |
| Product Code | JSY |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816085023861 | K880990 | 000 |