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FDA 510(k)

PHADEBAS/PHADEZYM IGE REAGENTS

K-Number: K813189 · 1981-12-31

ApplicantPharmacia, Inc.
Decision Date1981-12-31
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PHADEBAS/PHADEZYM IGE REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813189. 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 PHADEBAS/PHADEZYM IGE REAGENTS?

PHADEBAS/PHADEZYM IGE REAGENTS is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Pharmacia, Inc.. The 510(k) number is K813189.

When did PHADEBAS/PHADEZYM IGE REAGENTS receive FDA 510(k) clearance?

PHADEBAS/PHADEZYM IGE REAGENTS received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813189.

Who is the listed applicant for PHADEBAS/PHADEZYM IGE REAGENTS?

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 PHADEBAS/PHADEZYM IGE REAGENTS?

The FDA product code for PHADEBAS/PHADEZYM IGE REAGENTS 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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