The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Pancreatic A-amylase Eps.
| Device ID | K895880 |
| 510k Number | K895880 |
| Device Name: | PANCREATIC A-AMYLASE EPS |
| Classification | Cresol Red Colorimetry, Carbon-dioxide |
| 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 | CIL |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-05 |
| Decision Date | 1989-12-19 |