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FDA 510(k)

MICROSTAT 2

K-Number: K984485 · 1999-01-13

ApplicantChemlink Laboratories, LLC
Decision Date1999-01-13
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MICROSTAT 2 is the device name listed in this FDA 510(k) record. The listed applicant is Chemlink Laboratories, LLC. It received FDA 510(k) clearance on 1999-01-13 under 510(k) number K984485. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSTAT 2?

MICROSTAT 2 is a medical device that received FDA 510(k) clearance on 1999-01-13. The listed applicant is Chemlink Laboratories, LLC. The 510(k) number is K984485.

When did MICROSTAT 2 receive FDA 510(k) clearance?

MICROSTAT 2 received FDA 510(k) clearance on 1999-01-13, under 510(k) number K984485.

Who is the listed applicant for MICROSTAT 2?

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

What is the FDA product code for MICROSTAT 2?

The FDA product code for MICROSTAT 2 is LRJ. This falls under the Clinical Lab category.

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Related Devices (Code: LRJ)

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

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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