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)

(FPIA) ASSAY BUFFER

K-Number: K871486 · 1987-05-08

ApplicantWindsor Laboratories, Inc.
Decision Date1987-05-08
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

(FPIA) ASSAY BUFFER is the device name listed in this FDA 510(k) record. The listed applicant is Windsor Laboratories, Inc.. It received FDA 510(k) clearance on 1987-05-08 under 510(k) number K871486. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the (FPIA) ASSAY BUFFER?

(FPIA) ASSAY BUFFER is a medical device that received FDA 510(k) clearance on 1987-05-08. The listed applicant is Windsor Laboratories, Inc.. The 510(k) number is K871486.

When did (FPIA) ASSAY BUFFER receive FDA 510(k) clearance?

(FPIA) ASSAY BUFFER received FDA 510(k) clearance on 1987-05-08, under 510(k) number K871486.

Who is the listed applicant for (FPIA) ASSAY BUFFER?

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

What is the FDA product code for (FPIA) ASSAY BUFFER?

The FDA product code for (FPIA) ASSAY BUFFER is JJF.

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 Windsor Laboratories, 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.

K873281CARBAMAZEPINE (FPIA) CALIBRATOR KITK873282CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAYK870390PHENOBARBITAL (FPIA) CALIBRATOR KITK870389DIGOXIN (FPIA) CALIBRATOR KITK864333DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAYK863625PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT

View all 19 devices →

Related Devices (Code: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, 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.

↑