N-Assay Tia Plasminogen Test Kit
FDA 510(k) K971985 · Crestat Diagnostics, Inc.
510(k) numberK971985
Submission
- Device name
- N-Assay Tia Plasminogen Test Kit
- Applicant
- Crestat Diagnostics, Inc.
Weston, CT, US - Received
- May 29, 1997
- Decision date
- October 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K980883 | N-Assay Glu-UlCFR · Traditional | 09/03/1998SE |
| K981276 | N-Assay L D-BilCIG · Traditional | 05/01/1998SE |
| K981289 | N-Assay L T-BilCIG · Traditional | 04/27/1998SE |
| K980902 | N-Assay L Ast/GotCIT · Traditional | 03/26/1998SE |
| K980900 | N-Assay Cpk-LCGS · Traditional | 03/26/1998SE |
| K972257 | N-Assay Tia Antithrombin III Test KitDDQ · Traditional | 10/20/1997SE |
| K964296 | N-Assay Tia Apo B Test KitDER · Traditional | 08/01/1997SE |
| K964294 | N-Assay Tia Apo A1/B Multi CalibratorDER · Traditional | 08/01/1997SE |
| K964292 | N-Assay Tia Apo A1 Test KitDER · Traditional | 08/01/1997SE |
| K965100 | N-Assay Tia ALPHA-1-ANTITRYPSIN Test KitDEM · Traditional | 07/14/1997SE |
Questions and answers
When was N-Assay Tia Plasminogen Test Kit cleared by the FDA?
N-Assay Tia Plasminogen Test Kit (K971985) received a 510(k) decision of Substantially Equivalent on October 20, 1997, 144 days after the submission was received.
What is the product code of K971985?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.