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)

CHEM TRAK LIQUID BILIRUBIN CONTROL

K-Number: K833097 · 1984-01-11

ApplicantMedical Analysis Systems, Inc.
Decision Date1984-01-11
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM TRAK LIQUID BILIRUBIN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1984-01-11 under 510(k) number K833097. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEM TRAK LIQUID BILIRUBIN CONTROL?

CHEM TRAK LIQUID BILIRUBIN CONTROL is a medical device that received FDA 510(k) clearance on 1984-01-11. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K833097.

When did CHEM TRAK LIQUID BILIRUBIN CONTROL receive FDA 510(k) clearance?

CHEM TRAK LIQUID BILIRUBIN CONTROL received FDA 510(k) clearance on 1984-01-11, under 510(k) number K833097.

Who is the listed applicant for CHEM TRAK LIQUID BILIRUBIN CONTROL?

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

What is the FDA product code for CHEM TRAK LIQUID BILIRUBIN CONTROL?

The FDA product code for CHEM TRAK LIQUID BILIRUBIN CONTROL is JJX.

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 Medical Analysis Systems, 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.

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

View all 107 devices →

Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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.

↑