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FDA 510(k)

BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER

K-Number: K853453 · 1985-09-30

Decision Date1985-09-30
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER is the device name listed in this FDA 510(k) record. The listed applicant is Bio Automed Systems, Inc.. It received FDA 510(k) clearance on 1985-09-30 under 510(k) number K853453. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER?

BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER is a medical device that received FDA 510(k) clearance on 1985-09-30. The listed applicant is Bio Automed Systems, Inc.. The 510(k) number is K853453.

When did BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER receive FDA 510(k) clearance?

BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER received FDA 510(k) clearance on 1985-09-30, under 510(k) number K853453.

Who is the listed applicant for BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER?

The FDA 510(k) record lists Bio Automed Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER?

The FDA product code for BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER is JJQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: JJQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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