TOBRAMYCIN RIA KIT— 510(k) K800743

Substantially Equivalent

Antibodies, Inc.

FDA 510(k) clearance K800743 for TOBRAMYCIN RIA KIT, Substantially Equivalent on 1980-04-16. Applicant: Antibodies, Inc.. Device class: 2.

Clearance details

Applicant: Antibodies, Inc.
Product code: Code KLB
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1980-04-03
Decision date: 1980-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLB

K060853 — ONLINE TDM TOBRAMYCIN2006-06-09
K012312 — IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)2001-08-20
K003341 — EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS2001-01-22
K904304 — DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD1990-10-26
K903192 — IL TOBRAMYCIN ASSAY1990-08-22

More clearances from Antibodies, Inc.

K890774 — GIARDEIA(TM)1989-04-04
K843590 — DETECT-A-STREP1984-10-30
K822892 — CORTISOL RIA KIT1982-11-01
K812749 — ULTRA-DIG1981-10-19
K812314 — CRITHIDNA ANTI-DNA TEST KIT1981-09-01

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