ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040— 510(k) K860453
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K860453 for ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040, Substantially Equivalent on 1986-02-19. Applicant: Sigma Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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- K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
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Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.