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FDA 510(k)

ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY

K-Number: K960274 · 1996-03-29

ApplicantOrgentec
Decision Date1996-03-29
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Orgentec. It received FDA 510(k) clearance on 1996-03-29 under 510(k) number K960274. 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 ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY?

ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY is a medical device that received FDA 510(k) clearance on 1996-03-29. The listed applicant is Orgentec. The 510(k) number is K960274.

When did ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY receive FDA 510(k) clearance?

ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY received FDA 510(k) clearance on 1996-03-29, under 510(k) number K960274.

Who is the listed applicant for ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY?

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

What is the FDA product code for ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY?

The FDA product code for ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY is JIR.

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Other records listing Orgentec 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.

K954830ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAYK954831ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAYK954829ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAYK954815ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAYK954814ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAYK954832ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY

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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

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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