Abs Cadkit
FDA 510(k) K910636 · Panbio, Inc.
510(k) numberK910636
Submission
- Device name
- Abs Cadkit
- Applicant
- Panbio, Inc.
Washington, DC, US - Received
- February 13, 1991
- Decision date
- April 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K941001 | Enzip Immunoturbidmetric Fibrinogen Assay KitGIS · Traditional | Diagnostic Specialties | 08/30/1994SE |
| 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 |
| 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 |
|---|---|---|
| K041068 | West Nile Virus Igg Indirect ElisaNOP · Traditional | 10/20/2004SE |
| K041231 | West Nile Virus Igm Capture Elisa, Model E-WNV02MNOP · Traditional | 08/10/2004SE |
| K030863 | Ebv VCA-P18 Igg ElisaLSE · Traditional | 06/27/2003SE |
| K002024 | Panbio Indx Igm Dip-S-Ticks Leptospirosis Test for the Detection of Igm Antibodies to…GRY · Traditional | 11/22/2000SE |
| K970189 | Fif TMKQJ · Traditional | 05/21/1997SE |
| K962176 | TPPMIF · Traditional | 10/18/1996SE |
Questions and answers
When was Abs Cadkit cleared by the FDA?
Abs Cadkit (K910636) received a 510(k) decision of Substantially Equivalent on April 29, 1991, 75 days after the submission was received.
What is the product code of K910636?
The FDA product code is GIS – Test, Fibrinogen, a Class II (moderate risk) device regulated under 21 CFR 864.7340.