ACON STREP A RAPID TEST STRIP— 510(k) K010582
Substantially EquivalentAcon Laboratories Co.
FDA 510(k) clearance K010582 for ACON STREP A RAPID TEST STRIP, Substantially Equivalent on 2001-05-07. 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
view allMore clearances from Acon Laboratories Co.
view all- K090057 — ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K061559 — ACON URINALYSIS REAGENT STRIPS
- 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
- 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 →
Recalls naming K010582
K-number listed on FDA's recall record- Z-2337-2025 — Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
- Z-3185-2024 — Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
- Z-1598-2022 — Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999. d. In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345. e. (added 11/30/22) Abbott Rapid Test Kit Acceava Infectious Disease Immunoassay Strep A Test Throat Swab Sample 50 Tests, Model Number: 92001
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010582.
Data sourced from openFDA. This site is unofficial and independent of the FDA.