510(k) K033414
- Device
- ACL TOP MODEL, TOP
- Applicant
- INSTRUMENTATION LABORATORY CO.
- 510(k) number
- K033414
- Product code
- GKP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-01-12
- Date received
- 2003-10-27
- Regulation
- 864.5400
- Classification name
- Instrument, Coagulation, Automated
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL MARBLE
- Address
- 180 Hartwell Rd. Bedford MA US 01730 01730
FDA Registration Numbers#
- 9613959
- 8043723
- 1217183
- 3006198300
- 3010362364
- 3010421384
- 3010188766
- 3009711478
- 3020704087
- 3037000637
- 9610806
- 1644474
- 3010960914
- 1181121
- 3002759288
- 2245451
- 2432235
Source Documents#
Other 510(k) Records For Product Code GKP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) | Instrumentation Laboratory (IL) Co. | 2024-08-16 |
| K231031 | ACL TOP Family 70 Series | Instrumentation Laboratory Company | 2023-06-21 |
| K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) | Instrumentation Laboratory CO | 2016-03-03 |
| K150877 | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS | Instrumentation Laboratory CO | 2015-12-13 |
| K091980 | ACL TOP 700 LAS | Instrumentation Laboratory CO | 2009-09-22 |
| K073377 | ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) | Instrumentation Laboratory CO | 2008-05-04 |
| K063679 | ACL TOP | Instrumentation Laboratory CO | 2007-01-12 |
| K031377 | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 | Dade Behring, Inc. | 2003-09-08 |
| K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | Fisher Diagnostics | 2002-12-09 |
| K020979 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 | Dade Behring, Inc. | 2002-06-27 |
| K001645 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | 2000-08-04 |
| K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | Bio/Data Corp. | 2000-07-12 |
| K001145 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | 2000-05-11 |
| K993299 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | 1999-12-07 |
| K993174 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | 1999-11-09 |
Legacy Summary#
summary
FDA Review#
Decision Summary