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FDA 510(k)

SERUM, CREATININE DETERMINATIONS

K-Number: K781884 · 1978-12-20

ApplicantFisher Scientific Co., LLC
Decision Date1978-12-20
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM, CREATININE DETERMINATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K781884. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM, CREATININE DETERMINATIONS?

SERUM, CREATININE DETERMINATIONS is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K781884.

When did SERUM, CREATININE DETERMINATIONS receive FDA 510(k) clearance?

SERUM, CREATININE DETERMINATIONS received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781884.

Who is the listed applicant for SERUM, CREATININE DETERMINATIONS?

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

What is the FDA product code for SERUM, CREATININE DETERMINATIONS?

The FDA product code for SERUM, CREATININE DETERMINATIONS is CGX.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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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