The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Ats Trichrome Stain (wheatley's Modification).
| Device ID | K881042 |
| 510k Number | K881042 |
| Device Name: | ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) |
| Classification | Stains, Microbiologic |
| Applicant | ALPHA-TEC SYSTEMS, INC. 18271 MCDURMOTT WEST, STE I Irvine, CA 92714 |
| Contact | Laurie A Williams |
| Correspondent | Laurie A Williams ALPHA-TEC SYSTEMS, INC. 18271 MCDURMOTT WEST, STE I Irvine, CA 92714 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-11 |
| Decision Date | 1988-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816085020785 | K881042 | 000 |
| 00816085023526 | K881042 | 000 |
| 00816085023465 | K881042 | 000 |
| 00816085021997 | K881042 | 000 |
| 00816085020839 | K881042 | 000 |
| 00816085020815 | K881042 | 000 |
| 00816085021867 | K881042 | 000 |
| 00816085022765 | K881042 | 000 |
| 00816085022529 | K881042 | 000 |