The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Pancreatic Amylase (pam) Reagent.
| Device ID | K013978 |
| 510k Number | K013978 |
| Device Name: | SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT |
| Classification | Catalytic Methods, Amylase |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD.,W-104 P.O. BOX 8000 Brea, CA 92822 -8000 |
| Contact | Mary Beth Tang |
| Correspondent | Mary Beth Tang BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD.,W-104 P.O. BOX 8000 Brea, CA 92822 -8000 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-03 |
| Decision Date | 2002-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590224448 | K013978 | 000 |