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FDA 510(k)

MODIFIED DELFIA ESTRADIOL KIT

K-Number: K902358 · 1990-06-18

ApplicantPharmacia, Inc.
Decision Date1990-06-18
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED DELFIA ESTRADIOL 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 1990-06-18 under 510(k) number K902358. The device is classified under product code CHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED DELFIA ESTRADIOL KIT?

MODIFIED DELFIA ESTRADIOL KIT is a medical device that received FDA 510(k) clearance on 1990-06-18. The listed applicant is Pharmacia, Inc.. The 510(k) number is K902358.

When did MODIFIED DELFIA ESTRADIOL KIT receive FDA 510(k) clearance?

MODIFIED DELFIA ESTRADIOL KIT received FDA 510(k) clearance on 1990-06-18, under 510(k) number K902358.

Who is the listed applicant for MODIFIED DELFIA ESTRADIOL 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 MODIFIED DELFIA ESTRADIOL KIT?

The FDA product code for MODIFIED DELFIA ESTRADIOL KIT is CHP.

Related Clinical Trials

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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: CHP)

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.

K041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMIbl GmbHK97390117 B-ESTRADIOL (ELISA)Kmi Diagnostics, Inc.K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.K970386ACS ESTADIOL-6 IIChiron Diagnostics Corp.K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)Johnson & Johnson Clinical Diagnostics, Inc.K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)Bio-Rad Laboratories, 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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