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FDA 510(k)

TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2

K-Number: K950128 · 1995-05-15

ApplicantEmd Chemicals, Inc.
Decision Date1995-05-15
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1995-05-15 under 510(k) number K950128. 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 TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2?

TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K950128.

When did TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 receive FDA 510(k) clearance?

TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 received FDA 510(k) clearance on 1995-05-15, under 510(k) number K950128.

Who is the listed applicant for TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2?

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

What is the FDA product code for TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2?

The FDA product code for TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 is CEK.

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Other records listing Emd Chemicals, Inc. as applicant

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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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