Cryocheck Clot Apcr
FDA 510(k) K060284 · Precision Biologic, Inc.
510(k) numberK060284
Submission
- Device name
- Cryocheck Clot Apcr
- Applicant
- Precision Biologic, Inc.
Dartmouth, N.S., CA - Received
- February 3, 2006
- Decision date
- May 10, 2006
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K941210 | Ptt-Lt Test KitGGW · Traditional | American Bioproducts Co. | 03/21/1995SESK |
More from American Bioproducts Co.
| 510(k) | Device | Decision |
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| K251440 | CRYOcheck Chromogenic Factor VIIIGGP · Traditional | 08/25/2025SE |
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| K214002 | CRYOcheck Chromogenic Factor IXGGP · Traditional | 12/23/2022SE |
| K193556 | Cryocheck Hex LAGFO · Traditional | 10/23/2020SE |
| K193204 | Cryocheck Chromogenic Factor VIIIGGP · Traditional | 07/17/2020SE |
| K183440 | CRYOcheck FVIII Inhibitor KitGGP · Traditional | 03/12/2019SE |
| K043571 | Cryocheck Clot SGGP · Traditional | 03/18/2005SE |
| K040987 | Cryocheck Clot CGGP · Traditional | 06/18/2004SE |
| K032804 | Cryocheck Weak Lupus Positive ControlGGC · Traditional | 11/03/2003SE |
| K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional | 04/28/2003SE |
Questions and answers
When was Cryocheck Clot Apcr cleared by the FDA?
Cryocheck Clot Apcr (K060284) received a 510(k) decision of Substantially Equivalent on May 10, 2006, 96 days after the submission was received.
What is the product code of K060284?
The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.