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

CET 1979-07-17

LIPASE REAGENT SET

Applicant Alta Diagnostics, Inc.

K-Number K790796

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JJX 1979-07-17

NORMAL PROTEIN ELECTROPHORESIS CONTROL

Applicant Beckman Instruments, Inc.

K-Number K791029

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KCN 1979-07-17

POPE OTO-WICK, STERILE & NON-STERILE

Applicant Xomed, Inc.

K-Number K791059

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JHI 1979-07-17

LABELED HUMAN CHORIONIC GONADOTROPHIN

Applicant Pcl-Ria, Inc.

K-Number K790876

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JSC 1979-07-17

BRAIN HEART INFUSION BROTH

Applicant Isle Media and Sterile Products, Inc.

K-Number K791194

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JJQ 1979-07-17

CARY 210 SERIES, SPECTROPHOTOMETER

Applicant Varian Assoc., Inc.

K-Number K791102

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KQI 1979-07-17

SICKLE-CELL F TEST

Applicant Isolab, Inc.

K-Number K791143

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JSC 1979-07-17

BRAIN HEART INFUSION WITH BROTH

Applicant Isle Media and Sterile Products, Inc.

K-Number K791291

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CFJ 1979-07-17

SPIN CHEM REAGENT, DETERMINATION OF LDH-

Applicant Smithkline Diagnostics, Inc.

K-Number K791081

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ESD 1979-07-17

MODEL CE-DM-II HEARING INSTRUMENT

Applicant Marcon Hearing Instruments, Inc.

K-Number K791126

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LDF 1979-07-12

SWAN-GANZ FLOW-DIRECTED CATHETER

Applicant Edwards Lifesciences, LLC

K-Number K791183

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KKX 1979-07-11

SURG-O-PAK, GOWNS, SHEETS, AND TOWELS

Applicant Convertors

K-Number K780627

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