The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Ats M/15 Phosphate Buffer, Product #034-42.
| Device ID | K881879 |
| 510k Number | K881879 |
| Device Name: | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 |
| Classification | Supplement, Culture Media |
| 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 | JSK |
| CFR Regulation Number | 866.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-04 |
| Decision Date | 1988-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816085023052 | K881879 | 000 |
| 00816085023021 | K881879 | 000 |
| 00816085022932 | K881879 | 000 |
| 00816085022918 | K881879 | 000 |
| 00816085022505 | K881879 | 000 |
| 00816085020716 | K881879 | 000 |
| 00816085020709 | K881879 | 000 |
| 00816085023342 | K881879 | 000 |