Clot 2 Semiautomatic Coagulation Analyzer
FDA 510(k) K900685 · Texas Intl. Laboratories, Inc.
510(k) numberK900685
Submission
- Device name
- Clot 2 Semiautomatic Coagulation Analyzer
- Applicant
- Texas Intl. Laboratories, Inc.
Needham, MA, US - Received
- February 12, 1990
- Decision date
- April 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQG – Instrument, Coagulation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Specialty
- Hematology
Other 510(k)s with product code KQG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050821 | Coagcare Anticoagulation Management SystemKQG · Traditional | Zycare | 08/16/2005SE |
| K021976 | FIBRON-1, FIBRON-4, Quikcoag, FibronKQG · Traditional | Vital Scientific N.V. | 10/25/2002SE |
| K992130 | Pacific Hemostasis Thromboscreen 400CKQG · Traditional | Pacific Hemostasis | 09/03/1999SE |
| K991321 | Pacific Hemostasis Thromboscreen 200KQG · Traditional | Pacific Hemostasis | 06/21/1999SE |
| K983475 | Hemochron ResponseKQG · Traditional | International Technidyne Corp. | 05/03/1999SE |
| K902614 | Elvi 828 Digiclot MultiscanKQG · Traditional | Logos Scientific, Inc. | 11/08/1990SE |
| K862047 | Coagulator (8 Channel)KQG · Traditional | Med USA | 09/29/1986SE |
| K852492 | CoagulatorKQG · Traditional | Med USA | 08/13/1985SE |
| K851169 | Electra 800 Automatic Coagulation TimerKQG · Traditional | Medical Laboratory Automation Systems, Inc. | 06/24/1985SE |
| K823131 | Koagulab 40-A Automated Coagulation SysKQG · Traditional | Ortho Diagnostic Systems, Inc. | 12/09/1982SE |
More from Ortho Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953643 | Hematil 18 (H-18)GKZ · Traditional | 03/22/1996SE |
| K904031 | Chema Chol Cholesterol SystemCHH · Traditional | 03/11/1991SE |
| K900684 | RDW and MPV Indices on Hemat 12GKZ · Traditional | 04/16/1990SE |
| K884006 | Hemat 12GKZ · Traditional | 12/05/1988SE |
| K883177 | H 10 or Hematil 10 Blood Cell & Platelet CounterGKZ · Traditional | 11/30/1988SE |
| K853722 | PLT-4 Platelet AnalyzerGKL · Traditional | 01/17/1986SE |
| K832886 | Flame Photometer T281-T282-T283JJO · Traditional | 12/08/1983SE |
| K832890 | Hemacomp 7 or Hematil 7GKL · Traditional | 10/19/1983SE |
| K831649 | Thermomixer S213-PHOTOANALYZER S263JJE · Traditional | 08/24/1983SE |
Questions and answers
When was Clot 2 Semiautomatic Coagulation Analyzer cleared by the FDA?
Clot 2 Semiautomatic Coagulation Analyzer (K900685) received a 510(k) decision of Substantially Equivalent on April 16, 1990, 63 days after the submission was received.
What is the product code of K900685?
The FDA product code is KQG – Instrument, Coagulation, a Class II (moderate risk) device regulated under 21 CFR 864.5400.