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FDA 510(k)

AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT

K-Number: K871505 · 1987-05-26

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

Device Summary

AUTOPAK NEONATAL TSH MONOCLONAL IRMA 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 K871505. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT?

AUTOPAK NEONATAL TSH MONOCLONAL IRMA 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 K871505.

When did AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT receive FDA 510(k) clearance?

AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT received FDA 510(k) clearance on 1987-05-26, under 510(k) number K871505.

Who is the listed applicant for AUTOPAK NEONATAL TSH MONOCLONAL IRMA 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 AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT?

The FDA product code for AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT is JLW.

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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 KITK870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KITK871008MICROMEDIC NEONATAL T4 KITK870245AUTOPAK TSH MONOCLONAL IRMA KITK862206TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER

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Related Devices (Code: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, 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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