Elvi Biclot 816
FDA 510(k) K812906 · Volu Sol Medical Industries
510(k) numberK812906
Submission
- Device name
- Elvi Biclot 816
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- October 19, 1981
- Decision date
- July 22, 1982
- 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 |
| K900685 | Clot 2 Semiautomatic Coagulation AnalyzerKQG · Traditional | Texas Intl. Laboratories, Inc. | 04/16/1990SE |
| 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 |
More from Medical Laboratory Automation Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822129 | Volu-Sol Bovins FixativeIGN · Traditional | 08/05/1982SE |
| K822128 | Volu-Sol Single Differential StainICN · Traditional | 08/05/1982SE |
| K822127 | Volu-Sol Zenkers FixativeIFH · Traditional | 08/05/1982SE |
| K822126 | Volu-Sol Carnoy FluidIGM · Traditional | 08/05/1982SE |
| K822038 | Volu-Sol Orange G-6(GILLS-MODHZH · Traditional | 08/03/1982SE |
| K822037 | Volu-Sol Tap Water SubstitutePPM · Traditional | 08/03/1982SE |
| K822036 | Volu-Sol DecalciferKDX · Traditional | 08/03/1982SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | 08/03/1982SE |
| K821541 | Hematoxylin IIIHYJ · Traditional | 06/10/1982SE |
| K821540 | Hematoxylin IIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Elvi Biclot 816 cleared by the FDA?
Elvi Biclot 816 (K812906) received a 510(k) decision of Substantially Equivalent on July 22, 1982, 276 days after the submission was received.
What is the product code of K812906?
The FDA product code is KQG – Instrument, Coagulation, a Class II (moderate risk) device regulated under 21 CFR 864.5400.