Fibri-Prest/Thrombin-Prest Controls
FDA 510(k) K884385 · American Bioproducts Co.
510(k) numberK884385
Submission
- Device name
- Fibri-Prest/Thrombin-Prest Controls
- Applicant
- American Bioproducts Co.
Parsippany, NJ, US - Received
- October 18, 1988
- Decision date
- December 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GJA – Test, Thrombin Time
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7875
- Specialty
- Hematology
Other 510(k)s with product code GJA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050817 | T-TekGJA · Traditional | R2 Diagnostics, Inc. | 12/12/2005SE |
| K982209 | Accuclot Thrombin Time Reagent Model A8713/A4589GJA · Traditional | Sigma Diagnostics, Inc. | 10/15/1998SE |
| K970645 | BC Thrombin ReagentGJA · Traditional | Behring Diagnostics, Inc. | 05/19/1997SE |
| K925493 | Biomerieux Hemolab Thrombicalci-TestGJA · Traditional | Biomerieux Vitek, Inc. | 04/21/1994SE |
| K930157 | Test ThrombinGJA · Traditional | Behring Diagnostics, Inc. | 05/14/1993SE |
| K923220 | Thrombin Clot Time Test ProcedureGJA · Traditional | Medical Laboratory Automation Systems, Inc. | 09/29/1992SE |
| K920147 | Thrombin Clotting Time ReagentGJA · Traditional | Helena Laboratories | 05/01/1992SE |
| K900126 | TT and HNTT by HemochronGJA · Traditional | International Technidyne Corp. | 02/05/1990SE |
| K894467 | Thrombin Time ReagentGJA · Traditional | Sigma Chemical Co. | 09/05/1989SE |
| K884384 | Thrombin-Prest Reagent KitGJA · Traditional | American Bioproducts Co. | 12/28/1988SE |
More from American Bioproducts Co.
| 510(k) | Device | Decision |
|---|---|---|
| K983460 | Star Automated Multi-Parametric AnalyzerJPA · Traditional | 11/12/1998SE |
| K971519 | Asserachrom Tpa Test KitGGP · Traditional | 08/19/1997SE |
| K964728 | Sta-Liatest D-Di Test KitDAP · Traditional | 06/26/1997SE |
| K964716 | Sta Liatest Control [N]+[P] KitGGN · Traditional | 06/26/1997SE |
| K964718 | Sta D-Di Calibrator KitDAP · Traditional | 05/23/1997SE |
| K962675 | Sta - Liatest VWF Test KitGJT · Traditional | 10/25/1996SE |
| K962671 | Sta-Vwf Calibrator KitGJT · Traditional | 09/13/1996SE |
| K962674 | Sta - VWF Control [N]+[P] KitGGN · Traditional | 07/23/1996SE |
| K961579 | Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional | 07/10/1996SE |
| K955040 | At-Iii Control Plasma KitGGC · Traditional | 01/31/1996SE |
Questions and answers
When was Fibri-Prest/Thrombin-Prest Controls cleared by the FDA?
Fibri-Prest/Thrombin-Prest Controls (K884385) received a 510(k) decision of Substantially Equivalent on December 28, 1988, 71 days after the submission was received.
What is the product code of K884385?
The FDA product code is GJA – Test, Thrombin Time, a Class II (moderate risk) device regulated under 21 CFR 864.7875.