MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA— 510(k) K982210
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K982210 for MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA, Substantially Equivalent on 1998-07-09. Applicant: Dade Behring, Inc.. Device class: 1.
Clearance details
- Applicant
- Dade Behring, Inc.
- Product code
- Code LJC
- Device class
- Class 1
- Regulation
- 21 CFR 866.3120
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
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