The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Reflotron(r) Alt (gpt).
| Device ID | K864082 |
| 510k Number | K864082 |
| Device Name: | REFLOTRON(R) ALT (GPT) |
| Classification | Hydrazone Colorimetry, Alt/sgpt |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Cheri Emmons |
| Correspondent | Cheri Emmons BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | CKD |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-20 |
| Decision Date | 1986-12-04 |