The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Ats Tb Rapid Stain Set Product #034-45.
| Device ID | K890148 |
| 510k Number | K890148 |
| Device Name: | ATS TB RAPID STAIN SET PRODUCT #034-45 |
| Classification | Carbol Fuchsin |
| Applicant | ALPHA-TEC SYSTEMS, INC. P.O. BOX 17196 Irvine, CA 92713 |
| Contact | Laurie A Williams |
| Correspondent | Laurie A Williams ALPHA-TEC SYSTEMS, INC. P.O. BOX 17196 Irvine, CA 92713 |
| Product Code | ICL |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-13 |
| Decision Date | 1989-01-24 |