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FDA 510(k)

DELFIA THYROXINE (T4) KIT

K-Number: K883559 · 1988-12-14

ApplicantPharmacia, Inc.
Decision Date1988-12-14
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA THYROXINE (T4) 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 1988-12-14 under 510(k) number K883559. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELFIA THYROXINE (T4) KIT?

DELFIA THYROXINE (T4) KIT is a medical device that received FDA 510(k) clearance on 1988-12-14. The listed applicant is Pharmacia, Inc.. The 510(k) number is K883559.

When did DELFIA THYROXINE (T4) KIT receive FDA 510(k) clearance?

DELFIA THYROXINE (T4) KIT received FDA 510(k) clearance on 1988-12-14, under 510(k) number K883559.

Who is the listed applicant for DELFIA THYROXINE (T4) 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 THYROXINE (T4) KIT?

The FDA product code for DELFIA THYROXINE (T4) KIT is CDX.

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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

View all 129 devices →

Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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