The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems G7 Amylase (amy7) Reagent With Model(s) A71607.
| Device ID | K091846 |
| 510k Number | K091846 |
| Device Name: | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 |
| Classification | Catalytic Methods, Amylase |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Marine Boyajian |
| Correspondent | Marine Boyajian BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-22 |
| Decision Date | 2009-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590206345 | K091846 | 000 |