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FDA 510(k)

DELFIA(TM) NEONATAL HTSH KIT

K-Number: K881627 · 1988-10-03

ApplicantPharmacia, Inc.
Decision Date1988-10-03
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA(TM) NEONATAL HTSH KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1988-10-03 under 510(k) number K881627. 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) NEONATAL HTSH KIT?

DELFIA(TM) NEONATAL HTSH KIT is a medical device that received FDA 510(k) clearance on 1988-10-03. The listed applicant is Pharmacia, Inc.. The 510(k) number is K881627.

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

DELFIA(TM) NEONATAL HTSH KIT received FDA 510(k) clearance on 1988-10-03, under 510(k) number K881627.

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

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

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

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

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Other records listing Pharmacia, 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.

K974350ALLERGAN IMMUNO CAP M4, M8, K70K972364UNICAP PHADIATOPK972068UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82K970420MASTERCAP AM 5.0/MASTERCAP RM 5.0K964152UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMHK962274UNICAP 100

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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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