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

GWF 1981-09-08

MODEL SIX BEAM SYSTEM

Applicant Braintech, Inc.

K-Number K811848

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FRC 1981-09-08

CASTLE TEC-TEST BIOLOGICAL INDICATOR

Applicant Sybron Corp.

K-Number K812272

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CDQ 1981-09-01

UREA NITROGEN (BUN)

Applicant Pointe Scientific, Inc.,

K-Number K812341

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CFR 1981-09-01

GLUCOSE-HK SYSTEM PACK TEST

Applicant Boehringer Mannheim Corp.

K-Number K812303

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CZP 1981-09-01

GELMAN IG-FIX KIT

Applicant Gelman Sciences, Inc.

K-Number K812253

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KJK 1981-09-01

AURAMINE O MYCROBACTERIAL STAIN SET

Applicant Carr-Scarborough Microbiologicals, Inc.

K-Number K812274

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KQI 1981-09-01

HELENA HBF QUIPLATE CONTROL

Applicant Helena Laboratories

K-Number K812226

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JBQ 1981-09-01

ANTITHROMBIN III SCREEN KIT

Applicant Pacific Hemostasis

K-Number K812215

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KNQ 1981-09-01

CELESTIN DILATOR

Applicant Inmed Corp.

K-Number K812289

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LFQ 1981-09-01

SANDARE URIC ACID PROCEDURE

Applicant Sandare Chemical Co., Inc.

K-Number K812313

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GQL 1981-09-01

HERPES VIRUS HOMINIS ANTIBODY TEST SYS.

Applicant Zeus Scientific, Inc.

K-Number K812085

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N/A 1981-09-01

LIPO-SEP CHOLESTEROL AUDIT SYSTEM

Applicant Isolab, Inc.

K-Number K812318

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