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FDA 510(k)

PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION

K-Number: K923832 · 1992-11-25

ApplicantKabi Pharmacia, Inc.
Decision Date1992-11-25
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Kabi Pharmacia, Inc.. It received FDA 510(k) clearance on 1992-11-25 under 510(k) number K923832. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION?

PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-11-25. The listed applicant is Kabi Pharmacia, Inc.. The 510(k) number is K923832.

When did PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION receive FDA 510(k) clearance?

PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION received FDA 510(k) clearance on 1992-11-25, under 510(k) number K923832.

Who is the listed applicant for PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION?

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

What is the FDA product code for PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION?

The FDA product code for PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION is DGC.

Related Clinical Trials

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.

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Other records listing Kabi 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.

K915083COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY

Related Devices (Code: DGC)

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.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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