THEOPHYLLINE TEST KIT REF. #A874799— 510(k) K880291

Name: FDA 510(k) clearance K880291
Creator: U.S. Food and Drug Administration
Published: 1988-03-24

Substantially Equivalent

Photec Diagnostics, Inc.

FDA 510(k) clearance K880291 for THEOPHYLLINE TEST KIT REF. #A874799, Substantially Equivalent on 1988-03-24. Applicant: Photec Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Photec Diagnostics, Inc.
Product code: Code LCA
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1988-01-25
Decision date: 1988-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little Falls, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCA

view all

K833789 — PHASE II THEOPHYLLINE RADIOIMMUNOASSAY1984-01-24
K821862 — QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.1982-07-06
K821347 — BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN.1982-05-28
K792062 — THEOPHYLLINE RIASSAY1980-02-25

More clearances from Photec Diagnostics, Inc.

view all

K897169 — QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT1990-02-23
K896329 — D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.1989-12-12
K894057 — QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT1989-08-31
K892224 — D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN1989-06-16
K890027 — QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD1989-04-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.