TRANSFERRIN NEPHELOMETRIC ASSAY— 510(k) K772253

Name: FDA 510(k) clearance K772253
Creator: U.S. Food and Drug Administration
Published: 1977-12-22

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K772253 for TRANSFERRIN NEPHELOMETRIC ASSAY, Substantially Equivalent on 1977-12-22. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 1977-12-09
Decision date: 1977-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DDG

view all

K240987 — Access sTfR2024-07-03
K190495 — Transferrin2020-03-16
K182095 — Tina-quant Transferrin ver.2 (urine application)2018-11-05
K120236 — TRANSFERRIN KIT FOR USE ON THE SPAPLUS2013-02-13
K080634 — ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A324952008-08-11

More clearances from Kallestad Laboratories, Inc.

view all

K863681 — PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM1986-12-03
K862917 — PATHFINDER ROTAVIRUS CHEMILUMINESCENT1986-10-22
K863682 — PATHFINDER(TM) SPECIMEN COLLECTION KIT1986-10-10
K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS1986-09-29
K862313 — KALLESTAD SM/RNP TEST REAGENT1986-08-06

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