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FDA 510(k)

DELFIA FREE THYROXINE (FT4) KIT

K-Number: K894605 · 1989-09-18

ApplicantPharmacia, Inc.
Decision Date1989-09-18
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DELFIA FREE THYROXINE (FT4) 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 1989-09-18 under 510(k) number K894605. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELFIA FREE THYROXINE (FT4) KIT?

DELFIA FREE THYROXINE (FT4) KIT is a medical device that received FDA 510(k) clearance on 1989-09-18. The listed applicant is Pharmacia, Inc.. The 510(k) number is K894605.

When did DELFIA FREE THYROXINE (FT4) KIT receive FDA 510(k) clearance?

DELFIA FREE THYROXINE (FT4) KIT received FDA 510(k) clearance on 1989-09-18, under 510(k) number K894605.

Who is the listed applicant for DELFIA FREE THYROXINE (FT4) 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 FREE THYROXINE (FT4) KIT?

The FDA product code for DELFIA FREE THYROXINE (FT4) KIT is CEC.

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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: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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