TREP CARD EIKEN
FDA 510(k) clearance K820567 · decided 1982-04-14
Clearance details
- K-number
- K820567
- Device name
- TREP CARD EIKEN
- Applicant
- Syn-Kit, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-02
- Decision date
- 1982-04-14
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- GMQ
- Device class
- 2
- Regulation number
- 866.3820
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.