MICROMEDIC LH & FSH RIA KIT— 510(k) K840188

Substantially Equivalent

Micromedic Systems

FDA 510(k) clearance K840188 for MICROMEDIC LH & FSH RIA KIT, Substantially Equivalent on 1984-03-23. Applicant: Micromedic Systems. Device class: 1.

Clearance details

Applicant: Micromedic Systems
Product code: Product code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1984-01-18
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Micromedic Systems

K923643 — MEDICOOL1993-03-31
K872309 — MICROMEDIC COMBOSTAT LH/FSH KIT1987-07-31
K870904 — MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT1987-05-26
K871008 — MICROMEDIC NEONATAL T4 KIT1987-05-26
K871505 — AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT1987-05-26

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