ACON URINALYSIS REAGENT STRIPS— 510(k) K061559
Substantially EquivalentAcon Laboratories Co.
FDA 510(k) clearance K061559 for ACON URINALYSIS REAGENT STRIPS, Substantially Equivalent on 2006-08-11. Applicant: Acon Laboratories Co.. Device class: 1.
Clearance details
- Applicant
- Acon Laboratories Co.
- Product code
- Code CDM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1785
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Recent devices under product code CDM
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view all- K090057 — ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K023766 — ACON STREP A TWIST TEST DEVICE
- 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
Recalls naming K061559
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061559.
Data sourced from openFDA. This site is unofficial and independent of the FDA.