CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM— 510(k) K780526
Substantially EquivalentI M, Inc.
FDA 510(k) clearance K780526 for CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM, Substantially Equivalent on 1978-04-28. Applicant: I M, Inc.. Device class: 2.
Clearance details
- Applicant
- I M, Inc.
- Product code
- Code GMD
- Device class
- Class 2
- Regulation
- 21 CFR 866.3165
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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