BIO-MONITOR AMIKACIN— 510(k) K780949

Substantially Equivalent

Monitor Science Corp.

FDA 510(k) clearance K780949 for BIO-MONITOR AMIKACIN, Substantially Equivalent on 1978-08-14. Applicant: Monitor Science Corp.. Device class: 2.

Clearance details

Applicant: Monitor Science Corp.
Product code: Code KLP
Device class: Class 2
Regulation: 21 CFR 862.3035
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 KLP

K032279 — ONLINE TDM AMIKA2003-10-10
K873426 — EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 166451987-10-29
K790899 — BACTEC1979-05-23

More clearances from Monitor Science Corp.

K790580 — RIA KIT, PROSTATIC ACID1979-05-25
K780950 — BIO-MONITOR TOBRAMYCIN1978-08-14
K780951 — BIO-MONITOR GENTAMICIN1978-08-14
K772038 — KANAMYCIN RIA1978-01-12
K772039 — BETA-HCG RIA1977-11-23

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