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

GHM 1983-07-28

SICKLE-HEME A/S CONTROLS & A/A CONTROL

Applicant Anco Medical Reagents & Assoc.

K-Number K831871

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JJQ 1983-07-28

MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC

Applicant Varian Assoc., Inc.

K-Number K831866

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EBF 1983-07-28

COMPOSI-GLAZE

Applicant Denpac Corp.

K-Number K831484

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DHN 1983-07-28

DNA FLOR

Applicant Medastat Scientific Corp.

K-Number K831408

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DXN 1983-07-28

LIFESTAT 200

Applicant Physio-Control Corp.

K-Number K831232

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CHL 1983-07-28

MODEL 947 VIDEO BLOOD GAS SYS

Applicant Avl Scientific Corp.

K-Number K831379

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CDM 1983-07-28

DIA STRIPS SYSTEM

Applicant California Immuno Diagnostic, Inc.

K-Number K831623

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JZQ 1983-07-28

REVOLUTION RADIAL IMMUNODIFFUSION PLATE

Applicant Calbiochem-Behring Corp.

K-Number K831811

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ESE 1983-07-28

INTRA-ORAL ARTIFICIAL LARYNX

Applicant Xomed, Inc.

K-Number K831127

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DSH 1983-07-28

AMBULATORY ECG EVENT RECORDER

Applicant Brentwood Instruments, Inc.

K-Number K830907

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PPM 1983-07-28

SODIUM HYPOCHLORITE 7%

Applicant Omega Medical Diagnostics

K-Number K831619

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DIF 1983-07-28

TRICYCLIC ANTIDEPRESSANTS

Applicant Utak Laboratories, Inc.

K-Number K831736

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