Aca Fibrinogen Test Pack
FDA 510(k) K812629 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK812629
Submission
- Device name
- Aca Fibrinogen Test Pack
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Mchenry, IL, US - Received
- September 14, 1981
- Decision date
- October 8, 1981
- 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 |
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Questions and answers
When was Aca Fibrinogen Test Pack cleared by the FDA?
Aca Fibrinogen Test Pack (K812629) received a 510(k) decision of Substantially Equivalent on October 8, 1981, 24 days after the submission was received.
What is the product code of K812629?
The FDA product code is KQJ – System, Fibrinogen Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7340.