GOAT ANTISERUM IGM NEPHELOMHTRIC— 510(k) K770963

Name: FDA 510(k) clearance K770963
Creator: U.S. Food and Drug Administration
Published: 1977-06-24

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K770963 for GOAT ANTISERUM IGM NEPHELOMHTRIC, Substantially Equivalent on 1977-06-24. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1977-05-27
Decision date: 1977-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DFT

view all

K983132 — IGM1998-11-04
K962201 — QUANTEX IGM1996-09-25
K955797 — IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR1996-04-05
K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS1994-12-12
K901453 — QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD1990-04-12

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.