ACON STREP A RAPID TEST STRIP
FDA 510(k) clearance K010582 · decided 2001-05-07
Clearance details
- K-number
- K010582
- Device name
- ACON STREP A RAPID TEST STRIP
- Applicant
- Acon Laboratories Co.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-27
- Decision date
- 2001-05-07
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- GTY
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 45812250 recall (Z-2337-2025) | Mckesson Medical-Surgical Inc. Corporate Office | 2025-08-18 |
| Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008 recall (Z-3185-2024) | Cypress Medical Products LLC | 2024-09-19 |
| Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectio recall (Z-1598-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |