DRUG CALIBRATOR II— 510(k) K962817
Substantially EquivalentDade Intl., Inc.
FDA 510(k) clearance K962817 for DRUG CALIBRATOR II, Substantially Equivalent on 1996-09-16. Applicant: Dade Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Intl., 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
- Newark, DE, US
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