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FDA 510(k)

DELFIA (TM) HTSH KIT

K-Number: K871644 · 1987-05-12

ApplicantLkb Instruments, Inc.
Decision Date1987-05-12
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA (TM) HTSH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1987-05-12 under 510(k) number K871644. 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 DELFIA (TM) HTSH KIT?

DELFIA (TM) HTSH KIT is a medical device that received FDA 510(k) clearance on 1987-05-12. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K871644.

When did DELFIA (TM) HTSH KIT receive FDA 510(k) clearance?

DELFIA (TM) HTSH KIT received FDA 510(k) clearance on 1987-05-12, under 510(k) number K871644.

Who is the listed applicant for DELFIA (TM) HTSH KIT?

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

What is the FDA product code for DELFIA (TM) HTSH KIT?

The FDA product code for DELFIA (TM) HTSH KIT is JLW.

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Other records listing Lkb Instruments, 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.

K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTERK872955DELFIA(TM) FERRITIN KITK871303DELFIA(TM) THYROXINE (T4) KITK871599DELFIA(TM) HIGE KITK864452DELFIA(TM) TRIIODOTHYRONINE (T3) KITK864733LKB 2260 MACROTOME

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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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