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FDA 510(k)

DURAZYME(R) CPK

K-Number: K883504 · 1988-09-13

ApplicantAmerican Monitor Corp.
Decision Date1988-09-13
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DURAZYME(R) CPK is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1988-09-13 under 510(k) number K883504. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURAZYME(R) CPK?

DURAZYME(R) CPK is a medical device that received FDA 510(k) clearance on 1988-09-13. The listed applicant is American Monitor Corp.. The 510(k) number is K883504.

When did DURAZYME(R) CPK receive FDA 510(k) clearance?

DURAZYME(R) CPK received FDA 510(k) clearance on 1988-09-13, under 510(k) number K883504.

Who is the listed applicant for DURAZYME(R) CPK?

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

What is the FDA product code for DURAZYME(R) CPK?

The FDA product code for DURAZYME(R) CPK is CGS.

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Other records listing American Monitor Corp. 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.

K895999PHOSPHORUSK896000ASPARTATE AMINOTRANFERASE (AST)K896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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Related Devices (Code: CGS)

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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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