MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL— 510(k) K813359
Substantially EquivalentAmerican Scientific Products
FDA 510(k) clearance K813359 for MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL, Substantially Equivalent on 1981-12-31. Applicant: American Scientific Products. Device class: 2.
Clearance details
- Applicant
- American Scientific Products
- Product code
- Code GMJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3320
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GMJ
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