CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST— 510(k) K972160
Substantially EquivalentTrinity Laboratories, Inc.
FDA 510(k) clearance K972160 for CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST, Substantially Equivalent on 1997-08-01. Applicant: Trinity Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Trinity Laboratories, Inc.
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raleigh, NC, US
Recent devices under product code DCK
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