Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

JPD 1980-07-21

HEMOHLOBIN A2 CONTROL-LYOPHILIZED

Applicant Isolab, Inc.

K-Number K801410

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ELS 1980-07-21

ZEST ENDODONTIC STABILIZER

Applicant Zest Anchors, Inc.

K-Number K801525

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EJS 1980-07-21

GDC 934

Applicant Deringer-Ney, Inc.

K-Number K801277

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KIF 1980-07-21

HYDRON ROOT CANAL FILLING MATERIAL

Applicant National Patent Development Corp.

K-Number K801482

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DXK 1980-07-21

ULTRA IMAGER

Applicant Honeywell, Inc.

K-Number K800553

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CEK 1980-07-21

TOTAL PROTEIN TEST

Applicant Environmental Chemical Specialties

K-Number K801061

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JQX 1980-07-21

ALBUMIN NEPHELOMETRIC ASSAY

Applicant J.T. Baker Chemical Co.

K-Number K801362

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JJS 1980-07-21

BLOOD GAS CONTROL PROD. NO. BG-1, BG-2

Applicant Health Diagnostics Corp.

K-Number K801449

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DRT 1980-07-21

A-V MINI CLINIC

Applicant Instromedix, Inc.

K-Number K800405

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N/A 1980-07-21

CYBREX PHENYTOIN

Applicant Abbott Laboratories

K-Number K801565

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ELW 1980-07-21

ASH BLUEPRINT ALGINATE IMPRESSION MATER.

Applicant Dentsply Intl.

K-Number K801587

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DXK 1980-07-21

SINVISION LINEAR ARRAY REAL TIME

Applicant Kt Medical, Inc.

K-Number K800653

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