Dimertest Latex Assay
FDA 510(k) K974596 · Agen Biomedical , Ltd.
510(k) numberK974596
Submission
- Device name
- Dimertest Latex Assay
- Applicant
- Agen Biomedical , Ltd.
Brisbane 4110, AU - Received
- December 9, 1997
- Decision date
- May 26, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7320
- Specialty
- Hematology
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More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K993276 | Simplify D-Dimer, Model DCGK1GHH · Traditional | 12/14/1999SE |
| K945642 | Agen Dimertest Gold EiaGHH · Traditional | 10/25/1995SE |
| K905643 | Bed Red D-Dimer Whole Blood Agglutination AssayGHH · Traditional | 04/12/1991SE |
| K890189 | Agen Dimertest EiaDAP · Traditional | 03/03/1989SE |
| K882944 | Dimertest(R) LatexDAP · Traditional | 08/17/1988SE |
Questions and answers
When was Dimertest Latex Assay cleared by the FDA?
Dimertest Latex Assay (K974596) received a 510(k) decision of Substantially Equivalent on May 26, 1998, 168 days after the submission was received.
What is the product code of K974596?
The FDA product code is DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 864.7320.