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

CGX 1981-06-25

CREATININE TEST

Applicant King Diagnostics, Inc.

K-Number K811664

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ITI 1981-06-25

POWERED WHEELCHAIR

Applicant The Oec Group

K-Number K811656

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JSG 1981-06-25

TRYPTIC SOY AGAR

Applicant Micro Media Laboratories

K-Number K811612

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JSI 1981-06-25

MANNITOL SALT AGAR

Applicant Micro Media Laboratories

K-Number K811609

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JHW 1981-06-25

CARDIOZYME PLUS CK-MB ITEM #65045

Applicant Harleco

K-Number K811573

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HRX 1981-06-25

SURGICAL INSTRUMENTS FOR USE W/ZIMMER

Applicant Zimmer, Inc.

K-Number K811675

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DLJ 1981-06-25

EMIT-ST SERUM PHENOBARBITAL CALIBRATOR

Applicant Syva Co.

K-Number K811622

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HRX 1981-06-25

ZIMMER ARTHROSCOPY SYSTEM

Applicant Zimmer, Inc.

K-Number K811596

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CEK 1981-06-25

TOTAL PROTEIN TEST

Applicant King Diagnostics, Inc.

K-Number K811673

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DKB 1981-06-25

EMIT-TOX SERUM CALIBRATORS

Applicant Syva Co.

K-Number K811620

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JHW 1981-06-25

CARDIOZYME PLUS CK-MB ITEM #65045 (G)

Applicant Harleco

K-Number K811575

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DCK 1981-06-25

QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.

Applicant Kallestad Laboratories, Inc.

K-Number K811617

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