Sigma Diagnostics Fibrinogen Kit (886A/887A)
FDA 510(k) K971858 · Sigma Diagnostics, Inc.
510(k) numberK971858
Submission
- Device name
- Sigma Diagnostics Fibrinogen Kit (886A/887A)
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- May 20, 1997
- Decision date
- October 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K923593 | Hemochron/Factor Vi Fibrinogen Assay and Cont PlasKQJ · Traditional | International Technidyne Corp. | 09/22/1992SE |
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| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
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Questions and answers
When was Sigma Diagnostics Fibrinogen Kit (886A/887A) cleared by the FDA?
Sigma Diagnostics Fibrinogen Kit (886A/887A) (K971858) received a 510(k) decision of Substantially Equivalent on October 9, 1997, 142 days after the submission was received.
What is the product code of K971858?
The FDA product code is KQJ – System, Fibrinogen Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7340.