Fibri-Prest Automate HA34
FDA 510(k) K840211 · Wellcome Diagnostics
510(k) numberK840211
Submission
- Device name
- Fibri-Prest Automate HA34
- Applicant
- Wellcome Diagnostics
Walker, MI, US - Received
- January 19, 1984
- Decision date
- March 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQJ – System, Fibrinogen Determination
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Specialty
- Hematology
Other 510(k)s with product code KQJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLKQJ · Special | Instrumentation Laboratory (IL) Co. | 07/24/2025SE |
| K073367 | Hemosil Fibrinogen-CKQJ · Special | Instrumentation Laboratory CO | 12/27/2007SE |
| K050928 | Dade Thrombin ReagentKQJ · Traditional | Dade Behring, Inc. | 06/29/2005SE |
| K971858 | Sigma Diagnostics Fibrinogen Kit (886A/887A)KQJ · Traditional | Sigma Diagnostics, Inc. | 10/09/1997SE |
| K970189 | Fif TMKQJ · Traditional | Panbio, Inc. | 05/21/1997SE |
| K965113 | N-Assay Tia Fibrinogen Test KitKQJ · Traditional | Crestat Diagnostics, Inc. | 04/16/1997SE |
| K934326 | Multifibren UKQJ · Traditional | Behring Diagnostics, Inc. | 04/19/1994SE |
| K931721 | Il Test Fibrinogen-CKQJ · Traditional | Instrumentation Laboratory CO | 08/13/1993SE |
| K922416 | Fibrinogen Rid Test KitKQJ · Traditional | The Binding Site, Ltd. | 03/09/1993SE |
| K925988 | MultifibrenKQJ · Traditional | Behring Diagnostics, Inc. | 03/01/1993SE |
More from Behring Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915203 | D-Dimer Wellcotest (HA10)DAP · Traditional | 01/31/1992SE |
| K910797 | Streptex Acid Extraction KitGTZ · Traditional | 03/29/1991SE |
| K895461 | Wellcolex Colour Shigella Test ZC51GNB · Traditional | 01/11/1990SE |
| K890146 | Wellcolex Colour Salmonella Test ZL 50GRM · Traditional | 02/16/1989SE |
| K875311 | Wellcozyme HSV WZO2GQN · Traditional | 08/03/1988SE |
| K861628 | Wellcozyme Rotavirus WZ01LIQ · Traditional | 01/21/1987SE |
| K864206 | Reveal Colour Strep a ZL16GTZ · Traditional | 01/13/1987SE |
| K861634 | The Wellcome Rotavirus Latex Test ZL40LIQ · Traditional | 10/29/1986SE |
| K854852 | Wellcogen Bacterial Antigen KitGTJ · Traditional | 02/04/1986SE |
| K854851 | Wellcogen N. Meningitidis B/E. Coli K1 ZL24GTJ · Traditional | 02/04/1986SE |
Questions and answers
When was Fibri-Prest Automate HA34 cleared by the FDA?
Fibri-Prest Automate HA34 (K840211) received a 510(k) decision of Substantially Equivalent on March 2, 1984, 43 days after the submission was received.
What is the product code of K840211?
The FDA product code is KQJ – System, Fibrinogen Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7340.