The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Analyte Carbon Dioxide Assayed On Technicon Ra(tm).
| Device ID | K880609 |
| 510k Number | K880609 |
| Device Name: | ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM) |
| Classification | Enzymatic, Carbon-dioxide |
| 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 | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-12 |
| Decision Date | 1988-03-16 |