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FDA 510(k)

ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM

K-Number: K945271 · 1995-04-20

ApplicantBio-Chem Laboratory Systems, Inc.
Decision Date1995-04-20
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Chem Laboratory Systems, Inc.. It received FDA 510(k) clearance on 1995-04-20 under 510(k) number K945271. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM?

ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-20. The listed applicant is Bio-Chem Laboratory Systems, Inc.. The 510(k) number is K945271.

When did ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM receive FDA 510(k) clearance?

ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM received FDA 510(k) clearance on 1995-04-20, under 510(k) number K945271.

Who is the listed applicant for ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM?

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

What is the FDA product code for ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM?

The FDA product code for ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM is JJE.

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Other records listing Bio-Chem Laboratory Systems, Inc. as applicant

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Related Devices (Code: JJE)

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.

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Official Source

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