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

JIS 1982-05-03

ACE ALBUMIN CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K-Number K821061

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JTO 1982-05-03

RAPID SST

Applicant Mds Laboratories, Inc.

K-Number K821040

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CEK 1982-05-03

RA-1000 SYSTEM ADD'L ANALYTES PHASE III

Applicant Technicon Instruments Corp.

K-Number K820913

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JIX 1982-05-03

NOVA II FLUIDS PACK

Applicant Shaban Mfg. Co.

K-Number K821030

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LHD 1982-05-03

RHYTHM WHEEL

Applicant Tropical Enterprises, Inc.

K-Number K813497

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BTG 1982-05-03

MICROBIOLOGY SPECIMEN BRUSH

Applicant Mill-Rose Laboratory

K-Number K820771

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BTR 1982-05-03

SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL

Applicant Shiley, Inc.

K-Number K821027

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CAI 1982-05-03

M T M CIRCUIT

Applicant Medical Technology Mix, Inc.

K-Number K821086

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FLS 1982-05-03

SYSTEM I INFANT MONITORING SYS

Applicant Burr Engineering & Development Co.

K-Number K820943

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KQN 1982-05-03

ACE ACTIVITY MICROVIAL TEST SET

Applicant Ventrex Laboratories, Inc.

K-Number K821011

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JTO 1982-05-03

AMS GRAM-POSITIVE IDENTIFICATION CARD

Applicant Vitek Systems, Inc.

K-Number K820264

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KGO 1982-05-03

DERMA PRENE

Applicant Ansell, Inc.

K-Number K820665

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