Thrombo Screeen Fibrin Degradation Product Kit
FDA 510(k) K852512 · Pacific Hemostasis
510(k) numberK852512
Submission
- Device name
- Thrombo Screeen Fibrin Degradation Product Kit
- Applicant
- Pacific Hemostasis
Ventura, CA, US - Received
- June 12, 1985
- Decision date
- September 17, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GHH – Fibrin Split Products
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7320
- Specialty
- Hematology
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| K042890 | Triage D-Dimer Test, Model 98100GHH · Traditional | Biosite Incorporated | 11/29/2004SE |
| K030740 | Modification to Tina-Quant D-Dimer Test SystemGHH · Special | Roche Diagnostics Corp. | 04/01/2003SE |
| K021877 | Mda D-DimerGHH · Traditional | bioMerieux, Inc. | 08/07/2002SE |
| K011143 | Tina-Quant D-Dimer Test SystemGHH · Special | Roche Diagnostics Corp. | 05/29/2001SE |
| K993276 | Simplify D-Dimer, Model DCGK1GHH · Traditional | Agen Biomedical , Ltd. | 12/14/1999SE |
| K972316 | Opus D-DimerGHH · Traditional | Behring Diagnostics, Inc. | 09/09/1997SE |
More from Behring Diagnostics, Inc.
| 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 Thrombo Screeen Fibrin Degradation Product Kit cleared by the FDA?
Thrombo Screeen Fibrin Degradation Product Kit (K852512) received a 510(k) decision of Substantially Equivalent on September 17, 1985, 97 days after the submission was received.
What is the product code of K852512?
The FDA product code is GHH – Fibrin Split Products, a Class II (moderate risk) device regulated under 21 CFR 864.7320.