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FDA 510(k)

CHROM Z CHROMOGENIC ASSAYS

K-Number: K951943 · 1995-11-13

ApplicantHelena Laboratories
Decision Date1995-11-13
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHROM Z CHROMOGENIC ASSAYS is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1995-11-13 under 510(k) number K951943. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROM Z CHROMOGENIC ASSAYS?

CHROM Z CHROMOGENIC ASSAYS is a medical device that received FDA 510(k) clearance on 1995-11-13. The listed applicant is Helena Laboratories. The 510(k) number is K951943.

When did CHROM Z CHROMOGENIC ASSAYS receive FDA 510(k) clearance?

CHROM Z CHROMOGENIC ASSAYS received FDA 510(k) clearance on 1995-11-13, under 510(k) number K951943.

Who is the listed applicant for CHROM Z CHROMOGENIC ASSAYS?

The FDA 510(k) record lists Helena Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROM Z CHROMOGENIC ASSAYS?

The FDA product code for CHROM Z CHROMOGENIC ASSAYS is JBQ.

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Other records listing Helena Laboratories as applicant

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Related Devices (Code: JBQ)

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Official Source

View on FDA Database →

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

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