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FDA 510(k)

FASTPACK TSH IMMUNOASSAY

K-Number: K101390 · 2010-08-13

ApplicantQualigen, Inc.
Decision Date2010-08-13
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FASTPACK TSH IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Qualigen, Inc.. It received FDA 510(k) clearance on 2010-08-13 under 510(k) number K101390. 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 FASTPACK TSH IMMUNOASSAY?

FASTPACK TSH IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2010-08-13. The listed applicant is Qualigen, Inc.. The 510(k) number is K101390.

When did FASTPACK TSH IMMUNOASSAY receive FDA 510(k) clearance?

FASTPACK TSH IMMUNOASSAY received FDA 510(k) clearance on 2010-08-13, under 510(k) number K101390.

Who is the listed applicant for FASTPACK TSH IMMUNOASSAY?

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

What is the FDA product code for FASTPACK TSH IMMUNOASSAY?

The FDA product code for FASTPACK TSH IMMUNOASSAY is JLW.

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Other records listing Qualigen, Inc. as applicant

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K182521FastPack IP Sex Hormone Binding Globulin ImmunoassayK123983FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERSK123725FASTPACK CONTROL KITK101388FASTPACK TESTO IMMUNOASSAYK072264FASTPACK HCG IMMUNOASSAYK062957FASTPACK TOTAL PSA METHOD VERIFICATION KIT

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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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