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FDA 510(k)

CARDIZYME PLUS LD #65094/93

K-Number: K832314 · 1983-09-01

ApplicantEm Industries, Inc.
Decision Date1983-09-01
Product CodeCFE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARDIZYME PLUS LD #65094/93 is the device name listed in this FDA 510(k) record. The listed applicant is Em Industries, Inc.. It received FDA 510(k) clearance on 1983-09-01 under 510(k) number K832314. The device is classified under product code CFE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIZYME PLUS LD #65094/93?

CARDIZYME PLUS LD #65094/93 is a medical device that received FDA 510(k) clearance on 1983-09-01. The listed applicant is Em Industries, Inc.. The 510(k) number is K832314.

When did CARDIZYME PLUS LD #65094/93 receive FDA 510(k) clearance?

CARDIZYME PLUS LD #65094/93 received FDA 510(k) clearance on 1983-09-01, under 510(k) number K832314.

Who is the listed applicant for CARDIZYME PLUS LD #65094/93?

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

What is the FDA product code for CARDIZYME PLUS LD #65094/93?

The FDA product code for CARDIZYME PLUS LD #65094/93 is CFE.

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Other records listing Em Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K823756ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082

Related Devices (Code: CFE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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