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Allergen Immunocap (C74 +17 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000132

by Pharmacia & Upjohn Co.

Identifiers

510(k) Number
K000132 FDA 510(k)
FDA Product Code
DHB FDA 510(k)
Models / Variants
C74 FDA 510(k)
E89 FDA 510(k)
Ex2 FDA 510(k)
Ex70 FDA 510(k)
Ex71 FDA 510(k)
Ex73 FDA 510(k)
Fx8 FDA 510(k)
Fx9 FDA 510(k)
Fx10 FDA 510(k)
Fx16 FDA 510(k)
Fx73 FDA 510(k)
I72 FDA 510(k)
I75 FDA 510(k)
I76 FDA 510(k)
K71 FDA 510(k)
K73 FDA 510(k)
K81 FDA 510(k)
K8 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5750 FDA 510(k)
Regulation Number
866.5750 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Allergen Immunocap (C74 +17 more) by Pharmacia & Upjohn Co. — Class II — FDA_510K — listed in FDA 510(k) — 18 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pharmacia & Upjohn Co.

Sources (1)

  • FDA 510(k) K000132 24 fields · synced Jun 18, 2026