The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Top Family 50 Series: Acl Top 350 Cts; Acl Top 550 Cts; Acl Top 750; Acl Top 750 Cts; Acl Top 750 Las.
| Device ID | K150877 |
| 510k Number | K150877 |
| Device Name: | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS |
| Classification | Instrument, Coagulation, Automated |
| Applicant | Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-01 |
| Decision Date | 2015-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950784067 | K150877 | 000 |
| 08426950784050 | K150877 | 000 |
| 08426950729242 | K150877 | 000 |
| 08426950784081 | K150877 | 000 |
| 08426950784074 | K150877 | 000 |