SM EIA DIAGNOSTIC KIT— 510(k) K870455

Name: FDA 510(k) clearance K870455
Creator: U.S. Food and Drug Administration
Published: 1987-03-17

Substantially Equivalent

Biohytech International, Inc.

FDA 510(k) clearance K870455 for SM EIA DIAGNOSTIC KIT, Substantially Equivalent on 1987-03-17. Applicant: Biohytech International, Inc.. Device class: 2.

Clearance details

Applicant: Biohytech International, Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1987-01-21
Decision date: 1987-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJM

view all

K182353 — EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay2018-11-27
K151559 — ImmuLisa Enhanced Centromere Antibody ELISA2016-03-11
K140493 — ELIA SCL-70S IMMUNOASSAY2014-10-30
K123880 — QUANTA FLASH CENTROMERE2014-02-07
K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT2014-01-28

More clearances from Biohytech International, Inc.

view all

K870453 — DS-DNA EIA DIAGNOSTIC KIT1987-03-24
K870452 — SS-DNA EIA DIAGNOSTIC KIT1987-03-17
K870456 — DNP EIA DIAGNOSTIC KIT1987-03-17
K870457 — RNP EIA DIAGNOSTIC KIT1987-03-17
K870458 — HISTONES EIA DIAGNOSTIC KIT1987-03-17

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