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FDA 510(k)

VENTRESCREEN BETA-HCG ENZYME IMMUNO

K-Number: K833909 · 1983-11-21

ApplicantVxr, Inc.
Decision Date1983-11-21
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VENTRESCREEN BETA-HCG ENZYME IMMUNO is the device name listed in this FDA 510(k) record. The listed applicant is Vxr, Inc.. It received FDA 510(k) clearance on 1983-11-21 under 510(k) number K833909. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTRESCREEN BETA-HCG ENZYME IMMUNO?

VENTRESCREEN BETA-HCG ENZYME IMMUNO is a medical device that received FDA 510(k) clearance on 1983-11-21. The listed applicant is Vxr, Inc.. The 510(k) number is K833909.

When did VENTRESCREEN BETA-HCG ENZYME IMMUNO receive FDA 510(k) clearance?

VENTRESCREEN BETA-HCG ENZYME IMMUNO received FDA 510(k) clearance on 1983-11-21, under 510(k) number K833909.

Who is the listed applicant for VENTRESCREEN BETA-HCG ENZYME IMMUNO?

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

What is the FDA product code for VENTRESCREEN BETA-HCG ENZYME IMMUNO?

The FDA product code for VENTRESCREEN BETA-HCG ENZYME IMMUNO is ETD.

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Other records listing Vxr, 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.

K853703VENTREZYME T3 IMMUNOASSAY T3K853748VENTRESCREEN HCG URINEK841456VENTREXYME EIA CONTROLS IMMUNOASSAYK840473VENTREZYME T4 IMMUNOASSAY T4K833960VENTREX PREGNANCY TEST KIT ENZYMEK833989VENTREZYME THEOPHYLLINE IMMUNOASSAY

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Related Devices (Code: ETD)

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.

K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc.K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))Aventamed DacK232702Solo+ Tympanostomy Tube Device (TTD)Aventamed DacK233658Biowy Tym Tube (TT)Biowy CorporationK232059Tympanostomy TubesGrace Medical, Inc.K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, 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.

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