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FDA 510(k)

MONO-PLUS(TM)

K-Number: K883004 · 1988-08-04

ApplicantWampole Laboratories
Decision Date1988-08-04
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MONO-PLUS(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Wampole Laboratories. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K883004. 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-PLUS(TM)?

MONO-PLUS(TM) is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Wampole Laboratories. The 510(k) number is K883004.

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

MONO-PLUS(TM) received FDA 510(k) clearance on 1988-08-04, under 510(k) number K883004.

Who is the listed applicant for MONO-PLUS(TM)?

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

What is the FDA product code for MONO-PLUS(TM)?

The FDA product code for MONO-PLUS(TM) is KTN.

Other records listing Wampole Laboratories 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.

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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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