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FDA 510(k)

DELFIA HTSH ULTRA KIT

K-Number: K923401 · 1992-11-30

ApplicantWallac OY
Decision Date1992-11-30
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA HTSH ULTRA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Wallac OY. It received FDA 510(k) clearance on 1992-11-30 under 510(k) number K923401. 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 HTSH ULTRA KIT?

DELFIA HTSH ULTRA KIT is a medical device that received FDA 510(k) clearance on 1992-11-30. The listed applicant is Wallac OY. The 510(k) number is K923401.

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

DELFIA HTSH ULTRA KIT received FDA 510(k) clearance on 1992-11-30, under 510(k) number K923401.

Who is the listed applicant for DELFIA HTSH ULTRA KIT?

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

What is the FDA product code for DELFIA HTSH ULTRA KIT?

The FDA product code for DELFIA HTSH ULTRA KIT is JLW.

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Other records listing Wallac OY 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.

K131284GSP NEONATAL BIOTINIDASE KITK100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UK081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITK071649NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BK070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

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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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