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FDA 510(k)

MICROMEDIC NEONATAL T4 KIT

K-Number: K871008 · 1987-05-26

ApplicantMicromedic Systems
Decision Date1987-05-26
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROMEDIC NEONATAL T4 KIT is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1987-05-26 under 510(k) number K871008. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROMEDIC NEONATAL T4 KIT?

MICROMEDIC NEONATAL T4 KIT is a medical device that received FDA 510(k) clearance on 1987-05-26. The listed applicant is Micromedic Systems. The 510(k) number is K871008.

When did MICROMEDIC NEONATAL T4 KIT receive FDA 510(k) clearance?

MICROMEDIC NEONATAL T4 KIT received FDA 510(k) clearance on 1987-05-26, under 510(k) number K871008.

Who is the listed applicant for MICROMEDIC NEONATAL T4 KIT?

The FDA 510(k) record lists Micromedic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROMEDIC NEONATAL T4 KIT?

The FDA product code for MICROMEDIC NEONATAL T4 KIT is CDX.

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Other records listing Micromedic Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K923643MEDICOOLK872309MICROMEDIC COMBOSTAT LH/FSH KITK871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KITK870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KITK870245AUTOPAK TSH MONOCLONAL IRMA KITK862206TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER

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Related Devices (Code: CDX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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