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)

CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS

K-Number: K894389 · 1989-10-12

ApplicantCatachem, Inc.
Decision Date1989-10-12
Product CodeGGX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K894389. The device is classified under product code GGX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS?

CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Catachem, Inc.. The 510(k) number is K894389.

When did CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS receive FDA 510(k) clearance?

CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS received FDA 510(k) clearance on 1989-10-12, under 510(k) number K894389.

Who is the listed applicant for CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS?

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

What is the FDA product code for CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS?

The FDA product code for CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS is GGX.

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 Catachem, 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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITK945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATED

View all 41 devices →

Related Devices (Code: GGX)

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.

K902263OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATIONTrimedyne, 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.

↑