Cryo Check Apc Resistant Plasma
FDA 510(k) K971222 · Precision Biologicals, Inc.
510(k) numberK971222
Submission
- Device name
- Cryo Check Apc Resistant Plasma
- Applicant
- Precision Biologicals, Inc.
Dartmouth, Nova Scotia, CA - Received
- April 2, 1997
- Decision date
- August 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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More from Cliniqa Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K982062 | Cryo-Check PNP Platelet Lysate, Model PNP-10GGW · Traditional | 01/13/1999SE |
| K981174 | Cryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and FDP12-15 (1.5ML)GJT · Traditional | 01/13/1999SE |
| K981173 | Cryo Check Factor Xi Deficient Plasma, Model FDP11-10 (1.OML) and FDP11-15 (1.5ML)GJT · Traditional | 01/13/1999SE |
| K971219 | Cryo Check Inr Validation SetGGN · Traditional | 08/29/1997SE |
| K971223 | Cryo Check Factor V Deficient PlasmaGJT · Traditional | 07/22/1997SE |
| K971227 | Cryo Check Factor X Deficient PlasmaGJT · Traditional | 07/18/1997SE |
| K971226 | Cryo Check Factor Ix Deficient PlasmaGJT · Traditional | 07/18/1997SE |
| K971225 | Cryo Check Factor Viii Deficient PlasmaGJT · Traditional | 07/17/1997SE |
| K971224 | Cryo Check Factor Vii Deficient PlasmaGJT · Traditional | 07/17/1997SE |
| K951823 | Cryo Check Low Fibrinogen ControlGGN · Traditional | 01/03/1996SE |
Questions and answers
When was Cryo Check Apc Resistant Plasma cleared by the FDA?
Cryo Check Apc Resistant Plasma (K971222) received a 510(k) decision of Substantially Equivalent on August 19, 1997, 139 days after the submission was received.
What is the product code of K971222?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.