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FDA 510(k)

SMAC (SEQUENTIAL MULT. ANALYSIS COMP.

K-Number: K792138 · 1979-11-13

ApplicantFisher Scientific Co., LLC
Decision Date1979-11-13
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMAC (SEQUENTIAL MULT. ANALYSIS COMP. 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 1979-11-13 under 510(k) number K792138. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMAC (SEQUENTIAL MULT. ANALYSIS COMP.?

SMAC (SEQUENTIAL MULT. ANALYSIS COMP. is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K792138.

When did SMAC (SEQUENTIAL MULT. ANALYSIS COMP. receive FDA 510(k) clearance?

SMAC (SEQUENTIAL MULT. ANALYSIS COMP. received FDA 510(k) clearance on 1979-11-13, under 510(k) number K792138.

Who is the listed applicant for SMAC (SEQUENTIAL MULT. ANALYSIS COMP.?

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 SMAC (SEQUENTIAL MULT. ANALYSIS COMP.?

The FDA product code for SMAC (SEQUENTIAL MULT. ANALYSIS COMP. is CEK.

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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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Related Devices (Code: CEK)

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.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,Inc.

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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