GAMMADAB LH RADIO-KIT #CA-1508— 510(k) K823476
Substantially EquivalentClinical Assays, Inc.
FDA 510(k) clearance K823476 for GAMMADAB LH RADIO-KIT #CA-1508, Substantially Equivalent on 1982-12-28. Applicant: Clinical Assays, Inc.. Device class: 1.
Clearance details
- Applicant
- Clinical Assays, Inc.
- Product code
- Code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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