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

JTO 1981-10-26

API GERM TUBE

Applicant Analytab Products, Inc.

K-Number K812862

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DFZ 1981-10-26

H-103 IGG, H-104 IGA, H-105 IGM

Applicant Immulok, Inc.

K-Number K812821

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GEE 1981-10-26

WHISK-R

Applicant Medi-Spec

K-Number K812694

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JTO 1981-10-26

IDS PORPHYRIN REAGENT

Applicant Innovative Diagnostic Systems, Inc.

K-Number K812859

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CIS 1981-10-26

OPTIONAL TOTAL CA-MODULE FOR IL 504/508

Applicant Instrumentation Laboratory CO

K-Number K812872

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DTB 1981-10-23

MEDTRONIC #4951

Applicant Medtronic Vascular

K-Number K812599

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IAF 1981-10-23

ACCRA LAB HEMOTOLOGY

Applicant Accra Laboratories, Inc.

K-Number K812848

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KHE 1981-10-23

HELENA COLOSCREEN METHOD

Applicant Helena Laboratories

K-Number K812428

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FMF 1981-10-23

MONOJECT M535 35CC SYRINGE

Applicant Sherwood Medical Co.

K-Number K812748

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BZO 1981-10-23

VENTILATOR CIRCUIT

Applicant Hudson Oxygen Therapy Sales Co.

K-Number K812774

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JTN 1981-10-23

MOXALACTAM 30MCG. SENSI-DISC

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K812844

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KSF 1981-10-23

AVI-D CONTROL

Applicant Ortho Diagnostic Systems, Inc.

K-Number K811713

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