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)

ACETAMINOPHEN STAT-PAK REAGENT SET

K-Number: K821969 · 1982-07-16

ApplicantClin Tech Diagnostics Corp.
Decision Date1982-07-16
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACETAMINOPHEN STAT-PAK REAGENT SET 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 1982-07-16 under 510(k) number K821969. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACETAMINOPHEN STAT-PAK REAGENT SET?

ACETAMINOPHEN STAT-PAK REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-07-16. The listed applicant is Clin Tech Diagnostics Corp.. The 510(k) number is K821969.

When did ACETAMINOPHEN STAT-PAK REAGENT SET receive FDA 510(k) clearance?

ACETAMINOPHEN STAT-PAK REAGENT SET received FDA 510(k) clearance on 1982-07-16, under 510(k) number K821969.

Who is the listed applicant for ACETAMINOPHEN STAT-PAK REAGENT SET?

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 ACETAMINOPHEN STAT-PAK REAGENT SET?

The FDA product code for ACETAMINOPHEN STAT-PAK REAGENT SET is LDP.

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.

K820076GLYCO-SEP REAGENT TEST SETK813185SALICYLATE STAT-PAKK810235ACETAMINOPHEN/SALICYLATE CONTROLK802432GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.

Related Devices (Code: LDP)

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.

K261364Atellica CH Acetaminophen 2 (ACTM)Siemens Healthcare Diagnostics, Inc.K202644AcetaminophenSekisui Diagnostics P.E.I., Inc.K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc.K110726ROCHE ACETAMINOPHEN ASSAYRoche DiagnosticsK100200ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138Siemens Healthcare DiagnosticsK081938ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30Genzyme Diagnostics P.E.I., 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.

↑