EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)— 510(k) K971600
Substantially EquivalentBehring Diagnostics, Inc.
FDA 510(k) clearance K971600 for EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH), Substantially Equivalent on 1997-06-25. Applicant: Behring Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Behring Diagnostics, Inc.
- Product code
- Code DKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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