CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
FDA 510(k) clearance K993812 · decided 1999-12-21
Clearance details
- K-number
- K993812
- Device name
- CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
- Applicant
- Hardy Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1999-11-10
- Decision date
- 1999-12-21
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JSM
- Device class
- 1
- Regulation number
- 866.2390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Santa Maria, CA, 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.