Anti Ds-Dna
FDA 510(k) K943291 · Sigma Diagnostics, Inc.
510(k) numberK943291
Submission
- Device name
- Anti Ds-Dna
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- July 8, 1994
- Decision date
- December 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LLL – Extractable Antinuclear Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
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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 |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
Questions and answers
When was Anti Ds-Dna cleared by the FDA?
Anti Ds-Dna (K943291) received a 510(k) decision of Substantially Equivalent on December 2, 1994, 147 days after the submission was received.
What is the product code of K943291?
The FDA product code is LLL – Extractable Antinuclear Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.