ACTIVE PSA ELISA (DSL-10-9700)— 510(k) K973243
Substantially EquivalentDiagnostic Systems Laboratories, Inc.
FDA 510(k) clearance K973243 for ACTIVE PSA ELISA (DSL-10-9700), Substantially Equivalent on 1998-08-03. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Systems Laboratories, Inc.
- 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
- Webster, TX, US
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