KOAGULAB 40-A AUTOMATED COAGULATION SYS
FDA 510(k) clearance K823131 · decided 1982-12-09
Clearance details
- K-number
- K823131
- Device name
- KOAGULAB 40-A AUTOMATED COAGULATION SYS
- Applicant
- Ortho Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-10-25
- Decision date
- 1982-12-09
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- KQG
- Device class
- 2
- Regulation number
- 864.5400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Carpinteria, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM (K050821) | Zycare | 2005-08-16 |
| FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (K021976) | Vital Scientific N.V. | 2002-10-25 |
| PACIFIC HEMOSTASIS THROMBOSCREEN 400C (K992130) | Pacific Hemostasis | 1999-09-03 |
| PACIFIC HEMOSTASIS THROMBOSCREEN 200 (K991321) | Pacific Hemostasis | 1999-06-21 |
| HEMOCHRON RESPONSE (K983475) | International Technidyne Corp. | 1999-05-03 |
| ELVI 828 DIGICLOT MULTISCAN (K902614) | Logos Scientific, Inc. | 1990-11-08 |
| CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER (K900685) | Texas Intl. Laboratories, Inc. | 1990-04-16 |
| COAGULATOR (8 CHANNEL) (K862047) | Med USA | 1986-09-29 |
| COAGULATOR (K852492) | Med USA | 1985-08-13 |
| ELECTRA 800 AUTOMATIC COAGULATION TIMER (K851169) | Medical Laboratory Automation Systems, Inc. | 1985-06-24 |
| ELVI BICLOT 816 (K812906) | Volu Sol Medical Industries | 1982-07-22 |
| ELVI 810 CLOTSCANNER (K791587) | Volu Sol Medical Industries | 1979-09-17 |
Recalls involving this device
No recalls on record reference this clearance.