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FDA 510(k)

PROGENE MICROALBUMINURIA SCREEN

K-Number: K882538 · 1989-03-13

ApplicantProgene Corp.
Decision Date1989-03-13
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROGENE MICROALBUMINURIA SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Progene Corp.. It received FDA 510(k) clearance on 1989-03-13 under 510(k) number K882538. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGENE MICROALBUMINURIA SCREEN?

PROGENE MICROALBUMINURIA SCREEN is a medical device that received FDA 510(k) clearance on 1989-03-13. The listed applicant is Progene Corp.. The 510(k) number is K882538.

When did PROGENE MICROALBUMINURIA SCREEN receive FDA 510(k) clearance?

PROGENE MICROALBUMINURIA SCREEN received FDA 510(k) clearance on 1989-03-13, under 510(k) number K882538.

Who is the listed applicant for PROGENE MICROALBUMINURIA SCREEN?

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 MICROALBUMINURIA SCREEN?

The FDA product code for PROGENE MICROALBUMINURIA SCREEN is JIR.

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 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.

K895294PROGENE IGE BEAD EIAK875125PROGENE(TM) IGE TEST

Related Devices (Code: JIR)

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.

K222921Minuteful-kidney testHealthy.Io, Ltd.K210069Minuteful - kidney testHealthy.Io, Ltd.K061419TECO MICROALBUMIN 2-1 COMBO STRIPSTeco DiagnosticsK022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25Diagnostic Chemicals, Ltd. (Usa)K001810URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTINGFlexsite Diagnostics, Inc.K994035IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15Diagnostic Chemicals , Ltd.

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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