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FDA 510(k)

BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30

K-Number: K981609 · 1998-06-03

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1998-06-03
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1998-06-03 under 510(k) number K981609. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30?

BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 is a medical device that received FDA 510(k) clearance on 1998-06-03. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K981609.

When did BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 receive FDA 510(k) clearance?

BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 received FDA 510(k) clearance on 1998-06-03, under 510(k) number K981609.

Who is the listed applicant for BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30?

The FDA product code for BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 is CIG.

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Other records listing Diagnostic Chemicals , Ltd. as applicant

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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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