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FDA 510(k)

PROGENE IGE BEAD EIA

K-Number: K895294 · 1989-09-21

ApplicantProgene Corp.
Decision Date1989-09-21
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PROGENE IGE BEAD EIA is the device name listed in this FDA 510(k) record. The listed applicant is Progene Corp.. It received FDA 510(k) clearance on 1989-09-21 under 510(k) number K895294. 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 PROGENE IGE BEAD EIA?

PROGENE IGE BEAD EIA is a medical device that received FDA 510(k) clearance on 1989-09-21. The listed applicant is Progene Corp.. The 510(k) number is K895294.

When did PROGENE IGE BEAD EIA receive FDA 510(k) clearance?

PROGENE IGE BEAD EIA received FDA 510(k) clearance on 1989-09-21, under 510(k) number K895294.

Who is the listed applicant for PROGENE IGE BEAD EIA?

The FDA 510(k) record lists Progene Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROGENE IGE BEAD EIA?

The FDA product code for PROGENE IGE BEAD EIA is DGC.

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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 Progene Corp. 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.

K882538PROGENE MICROALBUMINURIA SCREENK875125PROGENE(TM) IGE TEST

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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