PORPHOBILINOGEN (PBG)— 510(k) K961984
Substantially EquivalentTrace America, Inc.
FDA 510(k) clearance K961984 for PORPHOBILINOGEN (PBG), Substantially Equivalent on 1996-12-10. Applicant: Trace America, Inc.. Device class: 1.
Clearance details
- Applicant
- Trace America, Inc.
- Product code
- Code JNF
- Device class
- Class 1
- Regulation
- 21 CFR 862.1590
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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- K980030 — AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
- K973869 — TRACE REAGENT LINE FOR THE COBAS MIRA
Data sourced from openFDA. This site is unofficial and independent of the FDA.