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

GLQ 1982-12-28

PARA 12

Applicant Streck Laboratories, Inc.

K-Number K823498

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GKH 1982-12-28

DILULAB 230

Applicant Innovative Medical Systems, Inc.

K-Number K823522

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HZL 1982-12-28

PAPINCOLABU STAIN EA-36/50/65 & OG-6

Applicant Accra Laboratories, Inc.

K-Number K823329

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KNO 1982-12-28

ARM THROUGH FOR WHEELCHAIR BK-6459-01 &

Applicant Fred Sammons, Inc.

K-Number K823636

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GKL 1982-12-28

HEMATOLOGY ANALYZER

Applicant Abbott Diagnostics

K-Number K823344

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HLX 1982-12-28

5012 PARABOLIC STIMULATOR

Applicant Life-Tech Intl., Inc.

K-Number K822923

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ILS 1982-12-28

PLASTIC BREAK RESISTANT MIRROR

Applicant Fred Sammons, Inc.

K-Number K823606

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LHK 1982-12-28

CANDIDA DETECTION SYSTEM

Applicant Ramco Laboratories, Inc.

K-Number K823016

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DGC 1982-12-28

TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY

Applicant Hybritech, Inc.

K-Number K823507

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KNX 1982-12-28

PEDIATRIC URINE COLLECTOR

Applicant Sage Products, Inc.

K-Number K823411

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GKZ 1982-12-28

COULTER-COUNTER #S PLUS IV & LYSE S +D

Applicant Coulter Electronics, Inc.

K-Number K823355

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ESD 1982-12-28

HEARING AID UNITRON #UE4-H

Applicant Unitron Industries, Inc.

K-Number K823669

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