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FDA 510(k)

DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI

K-Number: K851338 · 1986-04-07

ApplicantDiagnostic Products Corp.
Decision Date1986-04-07
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1986-04-07 under 510(k) number K851338. 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 DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI?

DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K851338.

When did DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI receive FDA 510(k) clearance?

DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI received FDA 510(k) clearance on 1986-04-07, under 510(k) number K851338.

Who is the listed applicant for DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI?

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

What is the FDA product code for DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI?

The FDA product code for DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI is JIR.

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Other records listing Diagnostic Products 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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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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