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)

ALBUMIN SCREEN TEST

K-Number: K870516 · 1987-10-20

ApplicantSclavo, Inc.
Decision Date1987-10-20
Product CodeJIQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN SCREEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K870516. The device is classified under product code JIQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBUMIN SCREEN TEST?

ALBUMIN SCREEN TEST is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Sclavo, Inc.. The 510(k) number is K870516.

When did ALBUMIN SCREEN TEST receive FDA 510(k) clearance?

ALBUMIN SCREEN TEST received FDA 510(k) clearance on 1987-10-20, under 510(k) number K870516.

Who is the listed applicant for ALBUMIN SCREEN TEST?

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

What is the FDA product code for ALBUMIN SCREEN TEST?

The FDA product code for ALBUMIN SCREEN TEST is JIQ.

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 Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

View all 82 devices →

Related Devices (Code: JIQ)

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.

K013643AUSAM TOTAL ALBUMIN ASSAYAusam Biotecthnologies, Inc.K991800HEMOCHEK URINE COLLECTION KITOsborn Group, Inc.K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITDiagnostic SpecialtiesK965035IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENTBeckman Instruments, Inc.K944664WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATORWako Chemicals USA, Inc.K936202URINARY ALBUMIN TEST PACKDupont Medical Products

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.

↑