ELECSYS PSA (ON ELECSYS 1010)— 510(k) K974189
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K974189 for ELECSYS PSA (ON ELECSYS 1010), Substantially Equivalent on 1998-01-06. Applicant: Boehringer Mannheim Corp.. Device class: 2.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- Product code
- Code LTJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code LTJ
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