FDA 510(k)

NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT

K-Number: K903995 · 1990-12-13

Decision Date1990-12-13

Product CodeGHD

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1990-12-13 under 510(k) number K903995. The device is classified under product code GHD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT?

NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT is a medical device that received FDA 510(k) clearance on 1990-12-13. The listed applicant is Sigma Chemical Co.. The 510(k) number is K903995.

When did NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT receive FDA 510(k) clearance?

NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT received FDA 510(k) clearance on 1990-12-13, under 510(k) number K903995.

Who is the listed applicant for NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT?

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

What is the FDA product code for NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT?

The FDA product code for NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT is GHD.

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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.