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FDA 510(k)

AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT

K-Number: K942661 · 1995-01-17

ApplicantSealite Sciences, Inc.
Decision Date1995-01-17
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sealite Sciences, Inc.. It received FDA 510(k) clearance on 1995-01-17 under 510(k) number K942661. 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 AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT?

AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1995-01-17. The listed applicant is Sealite Sciences, Inc.. The 510(k) number is K942661.

When did AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT receive FDA 510(k) clearance?

AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT received FDA 510(k) clearance on 1995-01-17, under 510(k) number K942661.

Who is the listed applicant for AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT?

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

What is the FDA product code for AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT?

The FDA product code for AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT is JLW.

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Other records listing Sealite Sciences, Inc. 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.

K974551SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAYK972761SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYK970612SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAYK970483AQUALITE INTACT PTHK970188SEALITE SCIENCES, INC. AQUALITE PROLACTINK970085SEALITE SCIENCES AQUALITE FSH

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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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