IDI-STREP B ASSAY
FDA 510(k) clearance K022504 · decided 2002-11-18
Clearance details
- K-number
- K022504
- Device name
- IDI-STREP B ASSAY
- Applicant
- Infectio Diagnostic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-29
- Decision date
- 2002-11-18
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- NJR
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Baldwin, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.