The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Chem 1 System Acid Phosphatase (total).
| Device ID | K884747 |
| 510k Number | K884747 |
| Device Name: | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) |
| Classification | Acid Phosphatase, Naphthyl Phosphate |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard A Dwarica |
| Correspondent | Leonard A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CKB |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-14 |
| Decision Date | 1989-01-30 |