510(k) K050821
- Device
- COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
- Applicant
- ZYCARE
- 510(k) number
- K050821
- Product code
- KQG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-08-16
- Date received
- 2005-03-31
- Regulation
- 864.5400
- Classification name
- Instrument, Coagulation
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVE D HOLDAWAY
- Address
- 3804 Sweeten Creek Rd. Chapel Hill NC US 27514 27514
FDA Registration Numbers#
- 3002721930
- 1181121
- 1217183
- 1220649
Source Documents#
Other 510(k) Records For Product Code KQG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | Vital Scientific N.V. | 2002-10-25 |
| K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | Pacific Hemostasis | 1999-09-03 |
| K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | Pacific Hemostasis | 1999-06-21 |
| K983475 | HEMOCHRON RESPONSE | International Technidyne Corp. | 1999-05-03 |
| K902614 | ELVI 828 DIGICLOT MULTISCAN | Logos Scientific, Inc. | 1990-11-08 |
| K900685 | CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER | Texas Intl. Laboratories, Inc. | 1990-04-16 |
| K862047 | COAGULATOR (8 CHANNEL) | Med USA | 1986-09-29 |
| K852492 | COAGULATOR | Med USA | 1985-08-13 |
| K851169 | ELECTRA 800 AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1985-06-24 |
| K823131 | KOAGULAB 40-A AUTOMATED COAGULATION SYS | Ortho Diagnostic Systems, Inc. | 1982-12-09 |
| K812906 | ELVI BICLOT 816 | Volu Sol Medical Industries | 1982-07-22 |
| K791587 | ELVI 810 CLOTSCANNER | Volu Sol Medical Industries | 1979-09-17 |
| K770914 | INCUBATOR, PORTABLE, ACT-STAT | Thermolyne Corp. | 1977-08-04 |
Legacy Summary#
summary
FDA Review#
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