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

JTY 1981-07-23

GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)

Applicant Abbott Laboratories

K-Number K812078

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JJE 1981-07-23

KODAK EKTACHEM 400 ANALYZER

Applicant Eastman Kodak Company

K-Number K811919

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FNG 1981-07-23

CENTURY BATHING SYSTEM

Applicant Century Manufacturing Co.

K-Number K811901

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JLS 1981-07-23

PROGESTERONE DIRECT RIA KIT (125I)

Applicant Immunalysis Corporation

K-Number K811907

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EJH 1981-07-23

BASE METAL ALLOY

Applicant Dentsply Intl.

K-Number K811258

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JIX 1981-07-23

HITACHI 705 CALIBRATOR

Applicant Boehringer Mannheim Corp.

K-Number K811921

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DPO 1981-07-23

COAT-A-COUNT DIGOXIN RIA

Applicant Diagnostic Products Corp.

K-Number K811932

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FRN 1981-07-23

I.V. ADMIN. SETS FOR THE AMP MARK IV PMP

Applicant American Medical Products, Inc.

K-Number K811917

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CGE 1981-07-23

KING DIAGNOSTICS GLUCOSE-O TEST

Applicant King Diagnostics, Inc.

K-Number K811883

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GPW 1981-07-23

ANTIBODY TO CHLAMYDIA TRACHOMATIS

Applicant Electro-Nucleonics Laboratories, Inc.

K-Number K811570

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FMI 1981-07-23

VISITEC NEEDLE RANGE (GENERAL HOSPITAL)

Applicant Visitec Co.

K-Number K811966

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CGJ 1981-07-23

FOLLICLE STIMULATING HORMONE DIRECT RIA

Applicant Immunalysis Corporation

K-Number K811905

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