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)

REAGENTS SERUM CREATINE USING TECHICON

K-Number: K802156 · 1980-10-10

ApplicantPanmed, Inc.
Decision Date1980-10-10
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENTS SERUM CREATINE USING TECHICON is the device name listed in this FDA 510(k) record. The listed applicant is Panmed, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802156. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENTS SERUM CREATINE USING TECHICON?

REAGENTS SERUM CREATINE USING TECHICON is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Panmed, Inc.. The 510(k) number is K802156.

When did REAGENTS SERUM CREATINE USING TECHICON receive FDA 510(k) clearance?

REAGENTS SERUM CREATINE USING TECHICON received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802156.

Who is the listed applicant for REAGENTS SERUM CREATINE USING TECHICON?

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

What is the FDA product code for REAGENTS SERUM CREATINE USING TECHICON?

The FDA product code for REAGENTS SERUM CREATINE USING TECHICON is CGX.

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 Panmed, 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.

K852767ERYTHOCYTE CREATINEK820642SICKLE-CHECKK802161BIURET REAGENT & TOTAL PROTEIN BLANK SOLK802157BCG REAGENT SERUM ALBUMIN W/TECHNICONK802163CHLORIDE COLOR & CHLORIDE SAMPLE DILUENTK802155REAGENTS SERUM SODIUM USING THE TECH.

View all 16 devices →

Related Devices (Code: CGX)

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.

K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian HealthK242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical CorporationK210452Creatinine2Abbott Ireland Diagnostics DivisionK161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, 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.

↑