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

CDP 1978-03-02

TRIA-PEG RIA DIAG. KIT

Applicant Nuclear Diagnostics, Inc.

K-Number K780292

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DPG 1978-02-28

RIALYZE DIGOXIN

Applicant Miles Laboratories, Inc.

K-Number K780075

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GNT 1978-02-28

INFLUENZA HA ANTIGEN A/USSR

Applicant Flow Laboratories, Inc.

K-Number K780275

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ESD 1978-02-28

IN-THE-EAR HEARING AID, MODEL CE-3

Applicant Starkey Laboratories, Inc.

K-Number K780309

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JIT 1978-02-28

FLAME PHOTOMETER STANDARD

Applicant Alko Scientific Co.

K-Number K772153

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GDJ 1978-02-28

ULNAR-RADIAL APPROXIMATER

Applicant Edward Weck, Inc.

K-Number K780291

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HWB 1978-02-28

HIP PLATE REMOVAL INSTRUMENT

Applicant Richard'S Medical Equip., Inc.

K-Number K780300

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KIH 1978-02-28

BONE CEMENT APPLICATOR

Applicant Zimmer, Inc.

K-Number K780266

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GNS 1978-02-28

INFLUENZA HI PRESERUM

Applicant Flow Laboratories, Inc.

K-Number K780273

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GNT 1978-02-28

INFLUENZA HA ANTIGEN

Applicant Flow Laboratories, Inc.

K-Number K780272

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GNS 1978-02-28

INFLUENZA HI ANTISERUM

Applicant Flow Laboratories, Inc.

K-Number K780274

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CZJ 1978-02-28

LAS-R HUMAN IGD TEST

Applicant Hyland Therapeutic Div., Travenol Laboratories

K-Number K772327

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