MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB— 510(k) K901450
Substantially EquivalentIntl. Immunoassay Laboratories, Inc.
FDA 510(k) clearance K901450 for MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB, Substantially Equivalent on 1990-05-15. Applicant: Intl. Immunoassay Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Intl. Immunoassay Laboratories, Inc.
- Product code
- Code JHT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
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More clearances from Intl. Immunoassay Laboratories, Inc.
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