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FDA 510(k)

HMB ALLERGOGEN SKIN PRICK TEST NEEDLE

K-Number: K844221 · 1985-02-08

ApplicantAller/Guard, Inc.
Decision Date1985-02-08
Product CodeSCL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HMB ALLERGOGEN SKIN PRICK TEST NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Aller/Guard, Inc.. It received FDA 510(k) clearance on 1985-02-08 under 510(k) number K844221. The device is classified under product code SCL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HMB ALLERGOGEN SKIN PRICK TEST NEEDLE?

HMB ALLERGOGEN SKIN PRICK TEST NEEDLE is a medical device that received FDA 510(k) clearance on 1985-02-08. The listed applicant is Aller/Guard, Inc.. The 510(k) number is K844221.

When did HMB ALLERGOGEN SKIN PRICK TEST NEEDLE receive FDA 510(k) clearance?

HMB ALLERGOGEN SKIN PRICK TEST NEEDLE received FDA 510(k) clearance on 1985-02-08, under 510(k) number K844221.

Who is the listed applicant for HMB ALLERGOGEN SKIN PRICK TEST NEEDLE?

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

What is the FDA product code for HMB ALLERGOGEN SKIN PRICK TEST NEEDLE?

The FDA product code for HMB ALLERGOGEN SKIN PRICK TEST NEEDLE is SCL.

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.

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Related Devices (Code: SCL)

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.

K250983Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)Asistan MedikalK222385Bifurcated NeedleAnhui Tiankang Medical Technology Co., Ltd.K182582Oryum and Ovem Epidermal Deri Prick Test ApplicatorAllergy & Applicator Depot, LLCK172062AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TrayMedscience Science Research Group, Inc.K162917Allerhope Allergy Skin TesterProcare Industrial Co., LimitedK032528BD ECLIPSE BIFURCATED NEEDLEBecton, Dickinson & CO

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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