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FDA 510(k)

ENZYMATIC CO2

K-Number: K833724 · 1983-12-29

ApplicantAmerican Monitor Corp.
Decision Date1983-12-29
Product CodeCIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC CO2 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 1983-12-29 under 510(k) number K833724. The device is classified under product code CIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYMATIC CO2?

ENZYMATIC CO2 is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is American Monitor Corp.. The 510(k) number is K833724.

When did ENZYMATIC CO2 receive FDA 510(k) clearance?

ENZYMATIC CO2 received FDA 510(k) clearance on 1983-12-29, under 510(k) number K833724.

Who is the listed applicant for ENZYMATIC CO2?

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 ENZYMATIC CO2?

The FDA product code for ENZYMATIC CO2 is CIL.

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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: CIL)

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.

K922953SYSTEMATE CALCIUM TEST TECHNICON RA 1000Em Diagnostic Systems, Inc.K895880PANCREATIC A-AMYLASE EPSBoehringer Mannheim Corp.K800111CO2 CONTENTAmerican Monitor Corp.

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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