The following data is part of a premarket notification filed by Amresco, Inc. with the FDA for Calcium Reagent Code 7732, 7733, 7532 & 7432.
| Device ID | K902479 |
| 510k Number | K902479 |
| Device Name: | CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432 |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Contact | Patel, Ph.d. |
| Correspondent | Patel, Ph.d. AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. Solon, OH 44139 |
| Product Code | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-05 |
| Decision Date | 1990-07-17 |