MICROMEDIC NEONATAL T4 KIT— 510(k) K871008

Substantially Equivalent

Micromedic Systems

FDA 510(k) clearance K871008 for MICROMEDIC NEONATAL T4 KIT, Substantially Equivalent on 1987-05-26. Applicant: Micromedic Systems. Device class: 2.

Clearance details

Applicant: Micromedic Systems
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1987-03-13
Decision date: 1987-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsham, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDX

K961490 — ELECSYS T4 ASSAY1996-06-13
K954312 — ACTIVE THYROXINE RIA1995-10-07
K943416 — DELFIA NEONATAL THYROXINE KIT1995-03-10
K934384 — AXSYM(TM) TOTAL T41994-06-21
K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-1161993-10-18

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
K871505 — AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT1987-05-26
K870245 — AUTOPAK TSH MONOCLONAL IRMA KIT1987-04-01

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