Cryo-Check PNP Platelet Lysate, Model PNP-10
FDA 510(k) K982062 · Precision Biologicals, Inc.
510(k) numberK982062
Submission
- Device name
- Cryo-Check PNP Platelet Lysate, Model PNP-10
- Applicant
- Precision Biologicals, Inc.
Dartmouth, Nova Scotia, CA - Received
- June 15, 1998
- Decision date
- January 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGW – Test, Time, Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
Other 510(k)s with product code GGW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V)GGW · Special | Instrumentation Laboratory (IL) Co. | 03/20/2026SE |
| K090105 | Lupotek KCTGGW · Traditional | R2 Diagnostics, Inc. | 12/30/2010SE |
| K083729 | Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act.…GGW · Traditional | Aniara Diagnostica, LLC | 05/08/2009SE |
| K060284 | Cryocheck Clot ApcrGGW · Traditional | Precision Biologic, Inc. | 05/10/2006SE |
| K042762 | Pefakit Apc-R Factor V LeidenGGW · Traditional | Pentapharm , Ltd. | 12/22/2004SE |
| K033471 | Phospholin Es and Calcium ChlorideGGW · Traditional | R2 Diagnostics, Inc. | 02/04/2004SE |
| K992456 | Gradileiden V TestGGW · Traditional | Gradipore , Ltd. | 12/21/1999SE |
| K963111 | Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SGGW · Traditional | Chromogenix AB | 12/23/1996SE |
| K945940 | Coatest(R) Apc(Tm) ResistanceGGW · Traditional | Axis-Shield Doc AS | 08/07/1995SE |
| K941210 | Ptt-Lt Test KitGGW · Traditional | American Bioproducts Co. | 03/21/1995SESK |
More from American Bioproducts Co.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K971222 | Cryo Check Apc Resistant PlasmaGGN · Traditional | 08/19/1997SE |
| 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 PNP Platelet Lysate, Model PNP-10 cleared by the FDA?
Cryo-Check PNP Platelet Lysate, Model PNP-10 (K982062) received a 510(k) decision of Substantially Equivalent on January 13, 1999, 212 days after the submission was received.
What is the product code of K982062?
The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.