Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K950234 · 1995-06-14

ApplicantEmd Chemicals, Inc.
Decision Date1995-06-14
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: 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 1995-06-14 under 510(k) number K950234. 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 NUMBER: XXXXX/R1. R2?

TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 is a medical device that received FDA 510(k) clearance on 1995-06-14. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K950234.

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

TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 received FDA 510(k) clearance on 1995-06-14, under 510(k) number K950234.

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

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

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Emd Chemicals, Inc. 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.

K031367DUOPATH VEROTOXINS GLISA TESTK990516ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK981926ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK973054ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSK951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)K951750GLUCOSE TEST ITEM NUMBER 97375/94

View all 62 devices →

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.

↑