ACON STREP A TWIST TEST DEVICE— 510(k) K023766
Substantially EquivalentAcon Laboratories Co.
FDA 510(k) clearance K023766 for ACON STREP A TWIST TEST DEVICE, Substantially Equivalent on 2003-02-10. Applicant: Acon Laboratories Co.. Device class: 1.
Clearance details
- Applicant
- Acon Laboratories Co.
- Product code
- Code GTY
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code GTY
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- K061559 — ACON URINALYSIS REAGENT STRIPS
- K020313 — ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
- K010582 — ACON STREP A RAPID TEST STRIP
- K980736 — ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
Adverse events under product code GTY
product code GTY- Death
- 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.