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)

SALICYLATE STAT-PAK

K-Number: K813185 · 1981-11-24

ApplicantClin Tech Diagnostics Corp.
Decision Date1981-11-24
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SALICYLATE STAT-PAK is the device name listed in this FDA 510(k) record. The listed applicant is Clin Tech Diagnostics Corp.. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K813185. The device is classified under product code DKJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALICYLATE STAT-PAK?

SALICYLATE STAT-PAK is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Clin Tech Diagnostics Corp.. The 510(k) number is K813185.

When did SALICYLATE STAT-PAK receive FDA 510(k) clearance?

SALICYLATE STAT-PAK received FDA 510(k) clearance on 1981-11-24, under 510(k) number K813185.

Who is the listed applicant for SALICYLATE STAT-PAK?

The FDA 510(k) record lists Clin Tech Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SALICYLATE STAT-PAK?

The FDA product code for SALICYLATE STAT-PAK is DKJ.

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 Clin Tech Diagnostics Corp. 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.

K821969ACETAMINOPHEN STAT-PAK REAGENT SETK820076GLYCO-SEP REAGENT TEST SETK810235ACETAMINOPHEN/SALICYLATE CONTROLK802432GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.

Related Devices (Code: DKJ)

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.

K093939ADVIA CHEMISTRY SALICYLATE REAGENTSiemens Healthcare DiagnosticsK042329SALICYLATE-SL ASSAYDiagnostic Chemicals , Ltd.K020794SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K014173SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATORBeckman Coulter, Inc.K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULSyva Co.K981872SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40Diagnostic Chemicals , Ltd.

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.

↑