TB SUSCEPTIBILITY QUADS I AND II— 510(k) K920143
Substantially EquivalentRemel Co.
FDA 510(k) clearance K920143 for TB SUSCEPTIBILITY QUADS I AND II, Substantially Equivalent on 1992-06-09. Applicant: Remel Co.. Device class: 2.
Clearance details
- Applicant
- Remel Co.
- Product code
- Code MJD
- Device class
- Class 2
- Regulation
- 21 CFR 866.1700
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
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