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FDA 510(k)

PHADEXACT SERUM, ALLERGEN SPECIFIC IGE

K-Number: K840538 · 1984-03-23

ApplicantPharmacia, Inc.
Decision Date1984-03-23
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PHADEXACT SERUM, ALLERGEN SPECIFIC IGE is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840538. 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 PHADEXACT SERUM, ALLERGEN SPECIFIC IGE?

PHADEXACT SERUM, ALLERGEN SPECIFIC IGE is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Pharmacia, Inc.. The 510(k) number is K840538.

When did PHADEXACT SERUM, ALLERGEN SPECIFIC IGE receive FDA 510(k) clearance?

PHADEXACT SERUM, ALLERGEN SPECIFIC IGE received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840538.

Who is the listed applicant for PHADEXACT SERUM, ALLERGEN SPECIFIC IGE?

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 PHADEXACT SERUM, ALLERGEN SPECIFIC IGE?

The FDA product code for PHADEXACT SERUM, ALLERGEN SPECIFIC IGE is DGC.

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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: 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

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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