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FDA 510(k)

CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE

K-Number: K902083 · 1990-06-15

ApplicantHelena Laboratories
Decision Date1990-06-15
Product CodeGJT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1990-06-15 under 510(k) number K902083. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE?

CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE is a medical device that received FDA 510(k) clearance on 1990-06-15. The listed applicant is Helena Laboratories. The 510(k) number is K902083.

When did CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE receive FDA 510(k) clearance?

CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE received FDA 510(k) clearance on 1990-06-15, under 510(k) number K902083.

Who is the listed applicant for CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE?

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-TROL CAT. NO. 5300 W/ NEW ANALYTE?

The FDA product code for CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE is GJT.

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Official Source

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