The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Co2 Alkaline Buffer Reagent Kit,prod#88813.
| Device ID | K925553 |
| 510k Number | K925553 |
| Device Name: | HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813 |
| Classification | Ph Rate Measurement, Carbon-dioxide |
| Applicant | HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Product Code | JFL |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-03 |
| Decision Date | 1993-02-12 |