The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Ats Cryptosporidium Stain Set.
| Device ID | K880989 |
| 510k Number | K880989 |
| Device Name: | ATS CRYPTOSPORIDIUM STAIN SET |
| 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 | 1988-03-08 |
| Decision Date | 1988-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816085022819 | K880989 | 000 |
| 00816085022802 | K880989 | 000 |