FDA 510(k)

DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A

K-Number: K060619 · 2006-07-21

Decision Date2006-07-21

Product CodeKHS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2006-07-21 under 510(k) number K060619. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A?

DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A is a medical device that received FDA 510(k) clearance on 2006-07-21. The listed applicant is Diazyme Laboratories. The 510(k) number is K060619.

When did DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A receive FDA 510(k) clearance?

DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A received FDA 510(k) clearance on 2006-07-21, under 510(k) number K060619.

Who is the listed applicant for DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A?

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

What is the FDA product code for DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A?

The FDA product code for DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A is KHS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.