Decision Date1983-02-25
Product CodeDHB
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
INHALANT PROFILE-ALLERGEN-SPECIFIC IGE is the device name listed in this FDA 510(k) record. The listed applicant is Mast Immunosystems. It received FDA 510(k) clearance on 1983-02-25 under 510(k) number K823593. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the INHALANT PROFILE-ALLERGEN-SPECIFIC IGE?
INHALANT PROFILE-ALLERGEN-SPECIFIC IGE is a medical device that received FDA 510(k) clearance on 1983-02-25. The listed applicant is Mast Immunosystems. The 510(k) number is K823593.
When did INHALANT PROFILE-ALLERGEN-SPECIFIC IGE receive FDA 510(k) clearance?
INHALANT PROFILE-ALLERGEN-SPECIFIC IGE received FDA 510(k) clearance on 1983-02-25, under 510(k) number K823593.
Who is the listed applicant for INHALANT PROFILE-ALLERGEN-SPECIFIC IGE?
The FDA 510(k) record lists Mast Immunosystems as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INHALANT PROFILE-ALLERGEN-SPECIFIC IGE?
The FDA product code for INHALANT PROFILE-ALLERGEN-SPECIFIC IGE is DHB.
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Official Source
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