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FDA 510(k)

HCL - 200 BIOCHEMISTRY ANALYZER

K-Number: K964409 · 1997-01-22

ApplicantHcl Laboratory Systems, Inc.
Decision Date1997-01-22
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCL - 200 BIOCHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Hcl Laboratory Systems, Inc.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K964409. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HCL - 200 BIOCHEMISTRY ANALYZER?

HCL - 200 BIOCHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Hcl Laboratory Systems, Inc.. The 510(k) number is K964409.

When did HCL - 200 BIOCHEMISTRY ANALYZER receive FDA 510(k) clearance?

HCL - 200 BIOCHEMISTRY ANALYZER received FDA 510(k) clearance on 1997-01-22, under 510(k) number K964409.

Who is the listed applicant for HCL - 200 BIOCHEMISTRY ANALYZER?

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

What is the FDA product code for HCL - 200 BIOCHEMISTRY ANALYZER?

The FDA product code for HCL - 200 BIOCHEMISTRY ANALYZER is JJF.

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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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