BIO-MONITOR GENTAMICIN— 510(k) K780951

Substantially Equivalent

Monitor Science Corp.

FDA 510(k) clearance K780951 for BIO-MONITOR GENTAMICIN, Substantially Equivalent on 1978-08-14. Applicant: Monitor Science Corp.. Device class: 2.

Clearance details

Applicant: Monitor Science Corp.
Product code: Code DKD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1978-06-09
Decision date: 1978-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DKD

K760942 — GENTASAK1977-03-07

More clearances from Monitor Science Corp.

K790580 — RIA KIT, PROSTATIC ACID1979-05-25
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K780950 — BIO-MONITOR TOBRAMYCIN1978-08-14
K772038 — KANAMYCIN RIA1978-01-12
K772039 — BETA-HCG RIA1977-11-23

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