GENTAMICIN RIA KIT— 510(k) K780516

Substantially Equivalent

Antibodies, Inc.

FDA 510(k) clearance K780516 for GENTAMICIN RIA KIT, Substantially Equivalent on 1978-04-28. Applicant: Antibodies, Inc.. Device class: 2.

Clearance details

Applicant: Antibodies, Inc.
Product code: Code DJB
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1978-03-30
Decision date: 1978-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJB

K832792 — AMES TDA SISOMICIN TEST-CONTROL SERUM1983-09-29
K831210 — GENTAMICIN TEST PACK-ACA1983-05-25
K821669 — AMES TDA GENTAMICIN TEST1982-12-15
K812394 — MRI GENTAMICIN RIA KIT1981-09-08
K811844 — COAT-A-COUNT GENTAMICIN RIA KIT1981-07-10

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.