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FDA 510(k)

MONO-PHILE

K-Number: K881247 · 1988-04-07

ApplicantBio Diagnostic Systems, Inc.
Decision Date1988-04-07
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MONO-PHILE 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 1988-04-07 under 510(k) number K881247. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONO-PHILE?

MONO-PHILE is a medical device that received FDA 510(k) clearance on 1988-04-07. The listed applicant is Bio Diagnostic Systems, Inc.. The 510(k) number is K881247.

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

MONO-PHILE received FDA 510(k) clearance on 1988-04-07, under 510(k) number K881247.

Who is the listed applicant for MONO-PHILE?

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 MONO-PHILE?

The FDA product code for MONO-PHILE is KTN.

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.

K821676PREG-PHILE B

Related Devices (Code: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

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.

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