ANTI-DNASE B REAGENT SYSTEM
FDA 510(k) clearance K790997 · decided 1979-07-24
Clearance details
- K-number
- K790997
- Device name
- ANTI-DNASE B REAGENT SYSTEM
- Applicant
- Calbiochem-Behring Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-05-29
- Decision date
- 1979-07-24
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- GTR
- Device class
- 1
- Regulation number
- 866.3720
- 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.