Enzip Immunoturbidmetric Fibrinogen Assay Kit
FDA 510(k) K941001 · Diagnostic Specialties
510(k) numberK941001
Submission
- Device name
- Enzip Immunoturbidmetric Fibrinogen Assay Kit
- Applicant
- Diagnostic Specialties
Metuchen, NJ, US - Received
- March 1, 1994
- Decision date
- August 30, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GIS – Test, Fibrinogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Specialty
- Hematology
Other 510(k)s with product code GIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control…GIS · Traditional | Diazyme Laboratories | 01/31/2016SE |
| K042919 | Fibrotek FibGIS · Traditional | R2 Diagnostics, Inc. | 11/29/2004SE |
| K993482 | K-Assay FibrinogenGIS · Traditional | Kamiya Biomedical Co. | 12/06/1999SE |
| K963902 | Quantitative Fibrinogen AssayGIS · Traditional | Ortho Diagnostic Systems, Inc. | 11/29/1996SE |
| K925494 | Biomerieux Hemolab FibrinomatGIS · Traditional | Biomerieux Vitek, Inc. | 05/18/1993SE |
| K923921 | Il Test PT Fibrinogen HSGIS · Traditional | Instrumentation Laboratory CO | 10/26/1992SE |
| K913061 | Fibrinogen Determination KitGIS · Traditional | Sigma Diagnostics, Inc. | 10/09/1991SE |
| K910636 | Abs CadkitGIS · Traditional | Panbio, Inc. | 04/29/1991SE |
| K903874 | Fibrinotest(Tm) - Fibrinogen AssayGIS · Traditional | Haemachem, Inc. | 02/14/1991SE |
| K881685 | Fibrinogentest-OGIS · Traditional | Diatech, Inc. | 08/09/1988SE |
More from Diatech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971458 | Enzip Immunoturbidimetric Microalbumin Assay KitJIQ · Traditional | 09/02/1997SE |
| K930823 | Protein-Bound Glucose Assayn KitLCP · Traditional | 08/19/1993SE |
| K922032 | Enzip Urinary Microalbumin TestJIR · Traditional | 07/30/1992SE |
| K831180 | Pregna-Cert, Slide Pregnancy TestJHJ · Traditional | 05/27/1983SE |
| K823109 | Generic Pregnancy TestLCX · Traditional | 11/10/1982SE |
| K813608 | Potassium Reagent SetCEJ · Traditional | 01/22/1982SE |
| K813412 | Glucose Enzyme-Color Reagent SetCGA · Traditional | 12/31/1981SE |
Questions and answers
When was Enzip Immunoturbidmetric Fibrinogen Assay Kit cleared by the FDA?
Enzip Immunoturbidmetric Fibrinogen Assay Kit (K941001) received a 510(k) decision of Substantially Equivalent on August 30, 1994, 182 days after the submission was received.
What is the product code of K941001?
The FDA product code is GIS – Test, Fibrinogen, a Class II (moderate risk) device regulated under 21 CFR 864.7340.