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)

PROTEIN ASSAY KIT

K-Number: K790808 · 1979-11-05

ApplicantSpecialty Medical Industries, Inc.
Decision Date1979-11-05
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROTEIN ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Medical Industries, Inc.. It received FDA 510(k) clearance on 1979-11-05 under 510(k) number K790808. 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 PROTEIN ASSAY KIT?

PROTEIN ASSAY KIT is a medical device that received FDA 510(k) clearance on 1979-11-05. The listed applicant is Specialty Medical Industries, Inc.. The 510(k) number is K790808.

When did PROTEIN ASSAY KIT receive FDA 510(k) clearance?

PROTEIN ASSAY KIT received FDA 510(k) clearance on 1979-11-05, under 510(k) number K790808.

Who is the listed applicant for PROTEIN ASSAY KIT?

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

What is the FDA product code for PROTEIN ASSAY KIT?

The FDA product code for PROTEIN ASSAY KIT 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 Specialty Medical Industries, 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.

K872968ULTRASCAN IGE ASSAY KITK862999ULTRASCAN CLINICAL ANALYZER

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.

↑