Pacific Hemostasis Thrombo-Screen Kaptt
FDA 510(k) K801460 · Pacific Hemostasis
510(k) numberK801460
Submission
- Device name
- Pacific Hemostasis Thrombo-Screen Kaptt
- Applicant
- Pacific Hemostasis
Mchenry, IL, US - Received
- June 24, 1980
- Decision date
- July 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K982062 | Cryo-Check PNP Platelet Lysate, Model PNP-10GGW · Traditional | Precision Biologicals, Inc. | 01/13/1999SE |
| 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 |
More from Axis-Shield Doc AS
| 510(k) | Device | Decision |
|---|---|---|
| K000679 | Thrombostrate Control PlasmasGGN · Traditional | 03/24/2000SE |
| K994100 | Pacific Hemostasis Thromboplastin DGJS · Traditional | 02/18/2000SE |
| K992130 | Pacific Hemostasis Thromboscreen 400CKQG · Traditional | 09/03/1999SE |
| K992279 | Heparin Control Plasma Level 2GGN · Traditional | 08/26/1999SE |
| K992278 | Heparin Control Plasma Level 1GGN · Traditional | 08/26/1999SE |
| K991321 | Pacific Hemostasis Thromboscreen 200KQG · Traditional | 06/21/1999SE |
| K990046 | Pacific Hemostasis Immunodepleted Factor Viii Deficient PlasmaGJT · Traditional | 02/17/1999SE |
| K984131 | Coagulation Control Level 3 (Abnormal)GGC · Traditional | 12/01/1998SE |
| K984130 | Coagulation Control Level 2 (Abnormal)GGC · Traditional | 12/01/1998SE |
| K984129 | Coagulation Control Level 1 (Normal)GIZ · Traditional | 12/01/1998SE |
Questions and answers
When was Pacific Hemostasis Thrombo-Screen Kaptt cleared by the FDA?
Pacific Hemostasis Thrombo-Screen Kaptt (K801460) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 34 days after the submission was received.
What is the product code of K801460?
The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.