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FDA 510(k)

CHEMWELL, MODEL 2900

K-Number: K010877 · 2001-05-23

ApplicantAwareness Technology, Inc.
Decision Date2001-05-23
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMWELL, MODEL 2900 is the device name listed in this FDA 510(k) record. The listed applicant is Awareness Technology, Inc.. It received FDA 510(k) clearance on 2001-05-23 under 510(k) number K010877. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMWELL, MODEL 2900?

CHEMWELL, MODEL 2900 is a medical device that received FDA 510(k) clearance on 2001-05-23. The listed applicant is Awareness Technology, Inc.. The 510(k) number is K010877.

When did CHEMWELL, MODEL 2900 receive FDA 510(k) clearance?

CHEMWELL, MODEL 2900 received FDA 510(k) clearance on 2001-05-23, under 510(k) number K010877.

Who is the listed applicant for CHEMWELL, MODEL 2900?

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

What is the FDA product code for CHEMWELL, MODEL 2900?

The FDA product code for CHEMWELL, MODEL 2900 is CIX.

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Other records listing Awareness Technology, 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.

K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)K013420CHEMWELL, ALSO KNOWN AS PROJECT 2900K974762STAT TRACKSK943729DYE CHECK STRIPS 545-630K941394STAT FAX 2600K923598REDI-CHECK PHOTMETER Q.A.

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Related Devices (Code: CIX)

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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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