RAICHEM(TM) SPIA(TM) IGA REAGENTS— 510(k) K894418
Substantially EquivalentReagents Applications, Inc.
FDA 510(k) clearance K894418 for RAICHEM(TM) SPIA(TM) IGA REAGENTS, Substantially Equivalent on 1989-08-02. Applicant: Reagents Applications, Inc.. Device class: 2.
Clearance details
- Applicant
- Reagents Applications, Inc.
- Product code
- Code CZP
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code CZP
view all- K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
- K060130 — IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
- K040435 — ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
- K024038 — N LATEX IGA
- K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
More clearances from Reagents Applications, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.