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 REAGENTS B6360-10

K-Number: K831627 · 1983-07-06

ApplicantAmerican Scientific Products
Decision Date1983-07-06
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE REAGENTS B6360-10 is the device name listed in this FDA 510(k) record. The listed applicant is American Scientific Products. It received FDA 510(k) clearance on 1983-07-06 under 510(k) number K831627. 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 CREATININE REAGENTS B6360-10?

CREATININE REAGENTS B6360-10 is a medical device that received FDA 510(k) clearance on 1983-07-06. The listed applicant is American Scientific Products. The 510(k) number is K831627.

When did CREATININE REAGENTS B6360-10 receive FDA 510(k) clearance?

CREATININE REAGENTS B6360-10 received FDA 510(k) clearance on 1983-07-06, under 510(k) number K831627.

Who is the listed applicant for CREATININE REAGENTS B6360-10?

The FDA 510(k) record lists American Scientific Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CREATININE REAGENTS B6360-10?

The FDA product code for CREATININE REAGENTS B6360-10 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 American Scientific Products 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.

K864824INFECTIOUS TISSUE KITK844042BLOOD DILUTION VIALK831634GLUCOSE REAGENT B6360-11K831625UREA NITROGEN-BUN-REAGENTS B6360-12K831626UREA NITROGEN-BUN-REAGENTS B6370-11AK831628CREATININE REAGENTS B6370-13

View all 28 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.

↑