Bactogen-H. Influenzae Type B

FDA 510(k) K800493 · Armkel, LLC

Substantially Equivalent

510(k) numberK800493

Submission

Device name
Bactogen-H. Influenzae Type B
Applicant
Armkel, LLC
Mchenry, IL, US
Received
March 4, 1980
Decision date
April 4, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GRO – Antisera, Fluorescent, All Types, Hemophilus Spp.
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3300
Specialty
Microbiology

Other 510(k)s with product code GRO

510(k)DeviceApplicantDecision
K851271Legionella Culture Confirmatin KitGRO · Traditional Gen-Probe, Inc.07/08/1985SE
K834067Legionella Differentiation DiskGRO · Traditional Remel Co.01/03/1984SE
K802423Phadebact Haemophilus TestGRO · Traditional Pharmacia, Inc.11/12/1980SE

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Questions and answers

When was Bactogen-H. Influenzae Type B cleared by the FDA?

Bactogen-H. Influenzae Type B (K800493) received a 510(k) decision of Substantially Equivalent on April 4, 1980, 31 days after the submission was received.

What is the product code of K800493?

The FDA product code is GRO – Antisera, Fluorescent, All Types, Hemophilus Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3300.