ACON STREP A RAPID TEST DEVICE
FDA 510(k) clearance K031784 · decided 2003-07-14
Clearance details
- K-number
- K031784
- Device name
- ACON STREP A RAPID TEST DEVICE
- Applicant
- ACON Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-10
- Decision date
- 2003-07-14
- Days to decision
- 34 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acc recall (Z-1074-2012) | Alere San Diego | 2012-02-22 |
| SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A R recall (Z-1395-2011) | Biosite Inc Dba Innovacon Inc. | 2011-02-22 |