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FDA 510(k)

PREG-PHILE B

K-Number: K821676 · 1982-07-16

ApplicantBio Diagnostic Systems, Inc.
Decision Date1982-07-16
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREG-PHILE B is the device name listed in this FDA 510(k) record. The listed applicant is Bio Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1982-07-16 under 510(k) number K821676. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREG-PHILE B?

PREG-PHILE B is a medical device that received FDA 510(k) clearance on 1982-07-16. The listed applicant is Bio Diagnostic Systems, Inc.. The 510(k) number is K821676.

When did PREG-PHILE B receive FDA 510(k) clearance?

PREG-PHILE B received FDA 510(k) clearance on 1982-07-16, under 510(k) number K821676.

Who is the listed applicant for PREG-PHILE B?

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

What is the FDA product code for PREG-PHILE B?

The FDA product code for PREG-PHILE B is JHJ.

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 Bio Diagnostic 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.

K881247MONO-PHILE

Related Devices (Code: JHJ)

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.

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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