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FDA 510(k)

BINAX L.S. TSH IRMA TEST KIT

K-Number: K873303 · 1987-10-02

ApplicantBinax, Inc.
Decision Date1987-10-02
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BINAX L.S. TSH IRMA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 1987-10-02 under 510(k) number K873303. 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 BINAX L.S. TSH IRMA TEST KIT?

BINAX L.S. TSH IRMA TEST KIT is a medical device that received FDA 510(k) clearance on 1987-10-02. The listed applicant is Binax, Inc.. The 510(k) number is K873303.

When did BINAX L.S. TSH IRMA TEST KIT receive FDA 510(k) clearance?

BINAX L.S. TSH IRMA TEST KIT received FDA 510(k) clearance on 1987-10-02, under 510(k) number K873303.

Who is the listed applicant for BINAX L.S. TSH IRMA TEST KIT?

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

What is the FDA product code for BINAX L.S. TSH IRMA TEST KIT?

The FDA product code for BINAX L.S. TSH IRMA TEST KIT is JLW.

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Other records listing Binax, Inc. as applicant

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K090301BINAXNOW PBP2A TEST, MODEL 890-000K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTK091489CLEARVIEW ADVANCED STREP A , MODEL 737-430K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010K092223MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

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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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