Sigma Diagnostics Alexin HS, Models A0969, A1094
FDA 510(k) K992711 · Sigma Diagnostics, Inc.
510(k) numberK992711
Submission
- Device name
- Sigma Diagnostics Alexin HS, Models A0969, A1094
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- August 11, 1999
- Decision date
- December 6, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GFO – Activated Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
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| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
| K013544 | Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096DAP · Traditional | 11/15/2001SE |
| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | 03/30/2001SE |
| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
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Questions and answers
When was Sigma Diagnostics Alexin HS, Models A0969, A1094 cleared by the FDA?
Sigma Diagnostics Alexin HS, Models A0969, A1094 (K992711) received a 510(k) decision of Substantially Equivalent on December 6, 1999, 117 days after the submission was received.
What is the product code of K992711?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.