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FDA 510(k)

UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH

K-Number: K964152 · 1997-04-23

ApplicantPharmacia, Inc.
Decision Date1997-04-23
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia, Inc.. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K964152. 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 UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH?

UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Pharmacia, Inc.. The 510(k) number is K964152.

When did UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH receive FDA 510(k) clearance?

UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH received FDA 510(k) clearance on 1997-04-23, under 510(k) number K964152.

Who is the listed applicant for UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH?

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 UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH?

The FDA product code for UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH is DGC.

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Other records listing Pharmacia, Inc. as applicant

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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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