STREPTOCOCCUS GR. D
FDA 510(k) clearance K840511 · decided 1984-03-23
Clearance details
- K-number
- K840511
- Device name
- STREPTOCOCCUS GR. D
- Applicant
- Scientific Device Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-06
- Decision date
- 1984-03-23
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- GTY
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.