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FDA 510(k)

GENZYME DIRECT AMYLASE VERIFIER

K-Number: K993132 · 1999-10-04

ApplicantGenzyme Corp.
Decision Date1999-10-04
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENZYME DIRECT AMYLASE VERIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 1999-10-04 under 510(k) number K993132. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENZYME DIRECT AMYLASE VERIFIER?

GENZYME DIRECT AMYLASE VERIFIER is a medical device that received FDA 510(k) clearance on 1999-10-04. The listed applicant is Genzyme Corp.. The 510(k) number is K993132.

When did GENZYME DIRECT AMYLASE VERIFIER receive FDA 510(k) clearance?

GENZYME DIRECT AMYLASE VERIFIER received FDA 510(k) clearance on 1999-10-04, under 510(k) number K993132.

Who is the listed applicant for GENZYME DIRECT AMYLASE VERIFIER?

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

What is the FDA product code for GENZYME DIRECT AMYLASE VERIFIER?

The FDA product code for GENZYME DIRECT AMYLASE VERIFIER is JIT.

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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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