Platelet Extract Reagent
FDA 510(k) K873382 · Bio/Data Corp.
510(k) numberK873382
Submission
- Device name
- Platelet Extract Reagent
- Applicant
- Bio/Data Corp.
Hatboro, PA, US - Received
- August 24, 1987
- Decision date
- November 20, 1987
- 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
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| 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 |
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| K893650 | Platelet Aggregation Profiler Model PAP-4CJPA · Traditional | 06/23/1989SE |
| K881150 | Kinetic Fibrinogen AssayGIS · Traditional | 03/28/1988SE |
| K860751 | Von Willebrand Fac. Defic. Abnormal Control PlasmaJPK · Traditional | 03/18/1986SE |
| K860342 | Microsample Coagulation Analyser, Model 110WPJPA · Traditional | 03/04/1986SE |
| K854546 | Microsample Coagulation Analyser Model 110PJPA · Traditional | 01/07/1986SE |
| K853897 | Citrex HGGW · Traditional | 10/10/1985SE |
| K853246 | Calcium ChlorideJPA · Traditional | 08/13/1985SE |
| K853078 | Citrex IIIJPA · Traditional | 08/12/1985SE |
Questions and answers
When was Platelet Extract Reagent cleared by the FDA?
Platelet Extract Reagent (K873382) received a 510(k) decision of Substantially Equivalent on November 20, 1987, 88 days after the submission was received.
What is the product code of K873382?
The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.