STAPHYLASE TEST
FDA 510(k) clearance K874303 · decided 1987-11-06
Clearance details
- K-number
- K874303
- Device name
- STAPHYLASE TEST
- Applicant
- Oxoid U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-10-20
- Decision date
- 1987-11-06
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- LHT
- Device class
- 1
- Regulation number
- 866.3700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Columbia, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.